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U.S. Department of Health and Human Services

Drugs

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Current Drug Shortages L - N

 

The majority of information in this section is provided to FDA by manufacturers. Communication between FDA and the public is an essential component of preventing and mitigating drug shortages. To ensure that the information in this section is current, FDA appreciates all information and updates about shortages provided by manufacturers. We post information about shortages as soon as we receive it from the manufacturers.  To report information about shortages or supply issues, manufacturers can send updates to drugshortages@fda.hhs.gov.  Healthcare professionals and patients are also encouraged to notify us of shortages at drugshortages@fda.hhs.gov.

*Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012

**Listed by Generic name or Active Ingredient**

A  B  C  D  E  F  G  H  I  K  [L – N]  O  P  Q  R  S  T  U  V  X  Y  Z

Leucovorin Calcium Lyophilized Powder for Injection

** Please note Levoleucovorin (Fusilev) is available in ample quantities**There is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev). The dose of levoleucovorin (Fusilev) is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin [Fusilev] 7.5 mg = racemic leucovorin 15 mg). For more information visit: Spectrum Pharmaceuticals web site.

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

Bedford Laboratories
Customer Service
1-800-562-4797 

50 mg (NDC 55390-0005-10)Available Demand increase for the drug.

Revised

4/2/2013

100 mg (NDC 55390-0052-10)Available
200 mg (NDC 55390-0053-01)Available
350mg (NDC 55390-0054-01)Available
500mg 50mL solution (NDC 55390-0009-01)The 500 mg / 50 mL solution is currently backordered and release dates are to be determined.
Teva Pharmaceuticals
1-800-545-8800
100mg/vial (NDC 0703-5140-01) 20mL Teva, in conjunction with the FDA, is initiating a temporary importation of Leucovorin Calcium Folinate Solution for Injection, to the United States market to address the current shortage. Teva has  the 30ml  presentation available , ndc 00703-2797-01

See Dear Healthcare Professional letter (PDF 692KB) for additional information.

 

Teva has limited inventory available of both presentations.

Regulatory delay.

Reverified 4/29/2013
350mg/vial (NDC 00703-5145-01) 30mL
APP Pharmaceuticals
1-888-386-1300
200 mg SDV (NDC 63323-710-50)Available. Check wholesalers for inventory.Shortage per Manufacturer:
Increased demand
Demand increase for the drug.

Revised 4/30/2013

500 mg SDV (NDC 63323-711-00)Currently back-ordered.  Next release anticipated May 2013.
Sagent Pharmaceuticals
1-866-625-1618
50 mg vial (NDC 25021-813-10)Available AvailableReverified 5/13/2013
100mg vial (NDC 25021-814-30)Available
200mg vial (NDC 25021-815-30)Available
350mg vial (NDC 25021-816-30)Available

 

Leuprolide Acetate Injection

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Teva
1-800-545-8800
1 mg/0.2 ml (NDC 00703-4014-18)Teva has Leuprolide Injection on backorder.  Teva anticipates product availability in Q2 2013. Requirements related to complying with good manufacturing practices

Reverified 4/29/2013

 
Sandoz
1-609-627-8500
1 mg/0.2 ml (NDC 00185-7400-85)Product now available  Other

Reverified 4/16/2013

Caraco
313-871-8400
1 mg/0.2 ml (NDC 41616-0936-40)On intermittent backorder.Shortage per Manufacturer:
Increase in demand
Demand increase for the drug. 

 

Levothyroxine sodium (Levoxyl) Tablets (Initial posting-3/15/2013)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Pfizer Customer Service
1-800-533-4535
25 mcg 100 ct
(NDC 60793-850-01)

Unavailable
 

Estimated Shortage Duration: Until 2014

Currently on backorder. 

 

For information on Levoxyl, please visit : http://www.levoxyl.com/ disclaimer icon

OtherRevised 4/5/2013 
25 mcg 1000 ct
(NDC 60793-850-10)
50 mcg 100 ct
(NDC 60793-851-01)
50 mcg 1000 ct
(NDC 60793-851-01)
75 mcg 100 ct
(NDC 60793-852-01)
75 mcg 1000 ct
(NDC 60793-852-10)
88 mcg 100 ct
(NDC 60793-853-01)
88 mcg 1000 ct
(NDC 60793-853-10)
100 mcg 100 ct
(NDC 60793-854-01)
100 mcg 1000 ct
(NDC 60793-854-10)
112 mcg 100 ct
(NDC 60793-855-01)
112 mcg 1000 ct
(NDC 60793-855-10)
125 mcg 100 ct
(NDC 60793-856-01)
125 mcg 1000 ct
(NDC 60793-856-10)
137 mcg 100 ct
(NDC 60793-857-01)
137 mcg 1000 ct
(NDC 60793-857-10)
150 mcg 100 ct
(NDC 60793-858-01)
150 mcg 1000 ct
(NDC 60793-858-10)
175 mcg 100 ct
(NDC 60793-859-01)
175 mcg 1000 ct
(NDC 60793-859-10)
200 mcg 100 ct
(NDC 60793-860-01)
200 mcg 1000 ct
(NDC 60793-860-10)

 

Lidocaine Hydrochloride (Xylocaine) Injection (Initial Posting Date) - 2/22/2012

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
APP Customer Service:
1-888-386-1300
Lidocaine 0.5% Xylocaine 0.5% injection 5 mg/mL, 50 mL vial (NDC 63323-0484-57)

Available. Check Wholesalers for inventory.   

 

All lidocaine and Xylocaine presentations are on intermittent back order and will be released as the product becomes available.

Shortage per Manufacturer:
Increase in demand

Demand increase for the drug.Reverified 4/30/2013
Xylocaine 0.5% - MPF injection, APP 5 mg/mL, 50 mL vial (NDC 63323-0491-57)Available. Check Wholesalers for inventory. 
Lidocaine 1% Lidocaine 1% injection 10 mg/mL, 2 mL vial (NDC 63323-0201-02Available. Check Wholesalers for inventory.
Lidocaine 1% Lidocaine 1% injection 10 mg/mL, 10 mL vial (NDC 63323-0201-10)Available. Check Wholesalers for inventory.
Xylocaine 1% injection 10 mg/mL, 20 mL vial (NDC 63323-0485-27)Available. Check Wholesalers for inventory.
Xylocaine 1% injection 10 mg/mL, 50 mL vial (NDC 63323-0485-57)Available. Check Wholesalers for inventory.
Xylocaine 1% - MPF injection 10 mg/mL, 2 mL vial (NDC 63323-0492-27)Available. Check Wholesalers for inventory.
Xylocaine 1% - MPF injection 10 mg/mL, 2 mL glass ampule (NDC 63323-0492-80)Available. Check Wholesalers for inventory.
Xylocaine 1% - MPF injection 10 mg/mL, 5 mL glass ampule (NDC 63323-0492-89)Backordered. No estimated delivery at this time.
Xylocaine 1% - MPF injection 10 mg/mL, 5 mL vial (NDC 63323-0492-57)Available. Check Wholesalers for inventory.
Xylocaine 1% - MPF injection 10 mg/mL, 30 mL vial (NDC 63323-0492-37)Available. Check Wholesalers for inventory.
Xylocaine 1% - MPF injection 10 mg/mL, 30 mL vial, sterile pack (NDC 63323-0492-31)Available. Check Wholesalers for inventory.
Lidocaine 1.5% Xylocaine 1.5% - MPF injection 15 mg/mL, 10 mL ampule (NDC 63323-0493-97)Backordered. No estimated delivery at this time.
Lidocaine 1.5% Xylocaine 1.5% - MPF injection 15 mg/mL, 20 mL ampule (NDC 63323-0493-91)Backordered. No estimated delivery at this time.
Lidocaine 2% Lidocaine 2% injection 20 mg/mL, 2 mL vial (NDC 63323-0202-02)Available. Check Wholesalers for inventory.
Lidocaine 2% injection 20 mg/mL, 5 mL SD Tear Top vial, preservative-free (NDC 63323-0208-05)Backordered.  Next release anticipated June 2013.
Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-17)Available. Check Wholesalers for inventory.
Xylocaine 2% injection 20 mg/mL, 20 mL vial (NDC 63323-0486-27)Available. Check Wholesalers for inventory.
Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-57)Available. Check Wholesalers for inventory.

Xylocaine 2% injection 20 mg/mL, 10 mL vial (NDC 63323-0486-10)

discontinued

 
Xylocaine 2% injection NDC discontinued 20 mg/mL, 20 mL vial (NDC 63323-0486-20)-NDC discontinued 
Xylocaine 2% injection 20 mg/mL, 50 mL vial (NDC 63323-0486-50) – NDC discontinued 
Xylocaine 2% - MPF injection 20 mg/mL, 2 mL vial (NDC 63323-0495-27)Available. Check Wholesalers for inventory.
Xylocaine 2% - MPF injection 20 mg/mL, 5 mL vial (NDC 63323-0495-07)Available. Check Wholesalers for inventory.
Xylocaine 2% - MPF injection 20 mg/mL, 10 mL ampule (NDC 63323-0496-97)Backordered. No Estimated delivery at this time..
Hospira, Inc. Customer Service: 1-877-946-7747
    
0.5% w/EPI 1:100,000; 1.8 mL Carpule (NDC 0409-0996-01)Next delivery 1Q 2013
Estimated recovery 2Q 2013

Please check with your wholesaler for available inventory. 

 

 

Shortage of Manufacturer: manufacturing delay/Availlable; Material shortage/Available

OtherRevised 5/3/2013
    
0.5% w/EPI 1:200,000; 50 mL vial (NDC 0409-3177-01)Available
1% w/EPI 1:100,000; 20 mL vial (NDC 0409-3178-01)Available 
1% w/EPI 1:100,000; 30 mL vial (NDC 0409-3178-02)Available
1% w/EPI 1:100,000; 50 mL vial (NDC 0409-3178-03)Next delivery May Estimated recovery: 2Q 2013
1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-01)Next delivery May
Estimated recovery 2Q 2013
 
1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-65)Available
1.5% w/EPI 1:200,000; 30 mL amp (NDC 0409-3181-01)Next delivery June Estimated recovery 2Q 2013
2% w/EPI 1:100,000; 20 mL vial (NDC 0409-3182-01)Available 
2% w/EPI 1:100,000; 30 mL vial (NDC 0409-3182-02)Available
2% w/EPI 1:100,000; 50 mL vial (NDC 0409-3182-03)Available
2% w/EPI 1:200,000; 20 mL vial (NDC 0409-3183-01)Next delivery June
Estimated recovery 2Q 2013
 
2% w Epi 1:50,000; 1.8mL syringe (NDC 0409-7263-01)Temporarily suspended
.0.5%; 50 mL FT  vial (NDC 0409-4275-01)Next delivery May Estimated recovery: 2Q 2013
0.5%; 50 mL TT vial (NDC 0409-4278-01)Available
1%; 5mL Ansyr Syringe (NDC 0409-9137-05)Next delivery April Estimated recovery 2Q 2013
5% w/7.5% Dex; 2mL amp (NDC 00409-4712-01)Next delivery May
Estimated recovery 2Q 2013
 
1%; 2 mL amp (NDC 0409-4713-32)Available
1%; 20 mL vial (NDC 0409-4276-01)

Available

1%; 30 mL vial (NDC 0409-4279-02)

Available

1%; 50 mL vial (NDC 0409-4276-02)Available
1%; 30 mL Sterile Pack vial (NDC 0409-4270-01)

Available

2%; 2 mL amp (NDC 0409-4282-01)

Available 

2%; 10 mL amp (NDC 0409-4282-02)Available
1%; 5 mL Abboject syringe (NDC 0409-4904-34)
Available
2%; 5 mL Abboject syringe (NDC 0409-4903-34)
Next delivery April
Estimated recovery 2Q 2013
2%; 5 mL vial (NDC 0409-2066-05)Available
2%; 20 mL vial (NDC 0409-4277-01)Available
2%; 50 mL vial (NDC 0409-4277-02)Available 
4%; 5 mL amp (NDC 0409-4283-01)Available
Product 1.5% w/EPI 1:200,000; 5 mL amp (NDC 0409-1209-65)Available
0.4% in 5% Dex; 500mL flex (NDC 00409-7931-24)Next delivery and estimated recovery 2014
0.4% I n5% Dex; 250mL flex (NDC 00409-7931-32)Next delivery and estimated recovery 2014
0.8% in 5% Dex; 250mL flex (NDC 00409-7939-32)Next delivery and estimated recovery 2014
2%; 5mL Ansyr syringe (NDC 0409-1323-05)

Next delivery April

Estimated recovery: 2Q 2013.

Amphastar Pharmaceuticals, Inc. Customer Service: 1-800-423-4136

2%, 5mL Luer-Jet Prefilled Syringe

NDC 76329-3390-1

(old NDC 0548-3390-00)
Amphastar will regularly release products.

Amphastar is experiencing a product shortage due to an increase in product demand caused by market supply issues.

Shortage per Manufacturer:
Increased Demand

Demand increase for the drug.

Reverified 5/13/2013

American Regent/Luitpold
1-800-645-1706

1%, 50 mL vial package of 25 (NDC 00517-0625-25)

UnavailableAmerican Regent/Luitpold has discontinued manufacturing Lidocaine HCl Injection, USPOtherReverified 5/7/2013
2%, 50 mL vial package of 25 (NDC 00517-0626-25)

 

Lidocaine HCl, 4% Topical Solution (Initial Posting 2/12/2013)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

Amphastar Pharmaceuticals, Inc. Customer Service:

1-800-423-4136

4mL Laryng-O-Jet

NDC 76329-6300-5

(old NDC 0548-6300-00) 

Available  N/A Revised 5/13/2013 

 

Liotrix (Thyrolar) Tablets

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Forest Pharmaceuticals
1-800-678-1605
 Forest has not yet reported when Thyrolar will be available.Shortage per Manufacturer:
Manufacturing delays
 Other 

 

Lomustine Capsules (Initial posting - 5/9/2013)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

NextSource Biotechnology, LLC

Customer Service:  1-855-672-2468

Lomustine capsules 10 mg: 5 count/bottle NDC 58181-3030-5 (Old BMS NDC# 0015-3030-20; 20 count/bottle) 

Limited supply available for allocation as of 5/16/2013- For emergency direct or drop shipment, contact customer service: 1-855-672-2468.
Continued releases anticipated.  Estimated recovery: 3Q 2013

Divestiture of ownership for Lomustine capsules from Bristol Myers Squibb Company (BMS) to Corden Pharma Latina S.p.A.
The new distributor in US market is NextSource Biotechnology LLC.

Corden Pharma Latina S.p.A./NextSource Biotechnology LLC is currently working with FDA to alleviate shortage.

See Dear Healthcare Professional Letterr (PDF - 113KB) for additional information

Other Revised 5/16/2013 
Lomustine capsules 40 mg: 5 count/bottle NDC 58181-3031-5 (Old BMS NDC# 0015-3031-20; 20 count/bottle)
Lomustine capsules 100 mg: 5 count/bottle NDC 58181-3032-5 (Old BMS NDC# 0015-3032-20; 20 count/bottle)Estimated recovery 3Q 2013

 

Lorazepam (Ativan) Injection 

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174
 

2 mg/mL, 1 mL vial
(NDC 0641-6001-25)

West-Ward currently has limited inventory of Lorazepam Injection, USP.


West-Ward has accelerated production on all Ativan/Lorazepam Injection product codes

West-Ward is anticipating having additional lots of inventory available in the March 2013 timeframe.


Product will be made available as it is released.
 

Demand increase for the drug

Revised-2/11/2013

2 mg/mL, 10 mL vial
(NDC 0641-6000-10)

On backorder

 

4 mg/mL, 1 mL vial
(NDC 0641-6003-25)

On backorder

 

4 mg/mL, 10 mL vial,
(NDC 0641-6002-10)

On backorder

 

2 mg/mL, 1 mL vial
(NDC 0641-6044-25)

Available

 

2 mg/mL, 10 mL vial,
(NDC 0641-6046-10)

Available

 

4 mg/mL, 1 mL vial
(NDC 0641-6045-25)

Available

 

4 mg/mL, 10 mL vial,
(NDC 0641-6047-10)

Available

 

Bedford Laboratories Customer Service:
1-800-562-4797

2 mg/mL, 1 mL vial (NDC 55390-0168-10), 10 mL vial (NDC 55390-0170-10)

Product Discontinued: Bedford currently has all presentations discontinued.

 Shortage per Manufacturer:
Not currently marketed.

Discontinuation of the manufacture of the drug.

 

Hospira Inc. Customer Service:
1-877-946-7747

2 mg/mL; 1 mL vial
(NDC 00409-6778-02)

Next delivery mid May

Estimated recovery 2Q 2013
 

Please check with your wholesaler for available inventory.

 

Shortage per Manufacturer:
Manufacturing delay/Available


 

 

Other

Demand increase for the drug.

Revised 5/3/2013

2 mg/mL; 10 mL vial
(NDC 0409-6780-02)

Available

2 mg/mL; 1 mL Carpuject syringe
(NDC 0409-1985-30)

Available

2 mg/mL; 1 mL iSecure syringe
(NDC 0409-1985-05)

Discontinued

4 mg/mL; 1 mL vial
(NDC 0409-6779-02)

Available

4 mg/mL; 10 mL vial
(NDC 0409-6781-02)

Next delivery early June

Estimated recovery: 2Q 2013

4 mg/mL; 1 mL
Carpuject syringe (NDC 0409-1539-31)

Temporarily unavailable

Akorn Pharmaceutical:
1-800-932-5676
 

2 mg/mL, 1 mL vial
(NDC 17478-0040-01)

Available

 NA

NA

Reverified
3/26/2012

Amphastar Pharmaceuticals, Inc./IMS
Customer Service:
1-800-423-4136
 
2mg/mL, 10 mL Vial (NDC 76329-8261-1)Available N/AReverified 5/13/2013

  

Magnesium Sulfate Injection

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
APP:
1-888-386-1300
500 mg/mL, 2 mL vial (NDC 63323-0064-02)Currently back-ordered. Next delivery expected May 2013. Check wholesalers for inventory.

Check wholesalers for inventory.  All other presentations are on intermittent back-order and the company is releasing product as it becomes available.

Shortage per Manufacturer:
Increased demand for the product.

Demand increase for the drug. Revised 4/30/2013
500 mg/mL, 10 mL vial (NDC 63323-0064-10)Currently back-ordered. Next release anticipated May 2013. Check wholesalers for inventory.
500 mg/mL, 20 mL vial (NDC 63323-0064-20)

Currently back-ordered.

Next delivery expected May 2013.

500 mg/mL, 50 mL vial (NDC 63323-0064-50)Currently back-ordered. Next delivery expected May 2013. Check wholesalers for inventory.
American Regent/Luitpold
1-800-645-1706
500 mg/mL, 2 mL vial (NDC 00517-2602-25)UnavailableShortage per Manufacturer: American Regent is currently not releasing Magnesium Sulfate Injection.OtherReverified 5/7/2013
500 mg/mL, 10 mL vial (NDC 00517-2610-25)
500 mg/mL, 50 mL vial (NDC 00517-2650-25)
Hospira, Inc. Customer Service
1-877-946-7747

      

50%; 20 mL vial

(NDC 0409-2168-02)

 

Next delivery and estimated recovery TBD

Please check with your wholesaler for available inventory. 

 

Shortages per Manufacturer: manufacturing delay

Other 

Revised 5/13/2013

50 %; 10 mL Ansyr syringe

(NDC 0409-1754-10)

Next delivery and estimated recovery TBD

40 mg/mL-water; 50 mL bag

(NDC 0409-6729-24)

Next delivery and estimated recovery TBD

40 mg/mL-water; 100 mL bag

(NDC 0409-6729-23)

Next delivery and estimated recovery TBD

40 mg/mL-water; 500 mL bag

(NDC 0409-6729-03)

Next delivery and estimated recovery TBD

40 mg/mL-water; 1000 mL bag

(NDC 0409-6729-09)

Available

10 mg/mL-dextrose; 100 mL bag

(NDC 0409-6727-23)

Next delivery and estimated recovery TBD

80 mg/mL-water; 50 mL bag

(NDC 0409-6730-13)

Next delivery and estimated recovery TBD

 

Mannitol Injection (Osmitrol, Resectisol) (Initial Posting Date) - 12/21/2011

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
APP
Customer Service:
1-888-386-1300
250 mg/mL, 50 mL vial, 25 count
(NDC 63323-0024-25)
Backordered. Check wholesalers for Inventory. Next delivery anticipated late May 2013.

APP has increased production and will have intermittent releases of product.

Shortage per Manufacturer:
Increase demand

Demand increase for the drug. Reverified 4/30/2013
B. Braun Medical Inc.
Customer Service:
1-800-227-2862
20% Mannitol Injection USP
500 mL flexible plastic container NDC 0264-7578-10 
All presentations available. 

 

 Revised 10/17/2012 
250 mL flexible plastic container NDC 0264-7578-20
Hospira, Inc.
Customer Service
1-877-946-7747
25%; 50 mL vial
(NDC 0409-4031-01)

Next delivery mid May. 
Estimated recovery: 2Q 2013.
 

Please check with your wholesaler for all available inventory.

Shortage per Manufacturer:
Manufacturing delay

Other Revised 5/3/2013
20%; 250 mL container
(NDC 0409-7715-02)
Available
20%; 500 mL container
(NDC 0409-7715-03)
Available
American Regent/Luitpold
1-800-645-1760
25%,  50 mL vial
NDC 0517-4050-25
UnavailableShortage per Manufacturer: American Regent is currently not releasing Mannitol Injection.Other

Reverified 5/7/2013

Baxter Customer Service:
1-800-ANA-DRUG
(1-800-262-3784)
20% OSMITROL Injection (20% Mannitol Injection, USP). NDC: 0338-0357-02AvailableShortage per Manufacturer:
Product Available
OtherReverified 5/7/2013
20% OSMITROL Injection (20% Mannitol Injection, USP). NDC: 0338-0357-03

 

Mecasermin [rDNA origin] (Increlex) Injection (Initial posting – 4/26/2012)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

Ipsen
Biopharmaceuticals
Inc.

Contact:
1-855-463-5127

INCRELEX
(mecasermin [rDNA origin] injection), 10 mg/mL
NDC-15054-1040-5
Ipsen
Biopharmaceuticals Inc. has limited product available and cannot estimate a release date for a new batches.

Ipsen Biopharmaceuticals, Inc.
(Ipsen) has been working with the Food and Drug Administration (FDA) in efforts to minimize any supply disruption. Current lots of Increlex in the marketplace were manufactured using an alternative drug substance manufacturing facility that has not been approved by the
FDA.

For more information on this release of supply, see Dear Healthcare Professional Letter (PDF - 49KB).

For more information regarding the anticipated drug shortage for Increlex, see Dear
Healthcare Professional Letter (PDF -  142KB)
.

Contact Ipsen Biopharmaceuticals Inc. regarding product availability. 

Relocation
of the third party manufactur ing site.

Shortage of the active ingredient

 

 

Methazolamide Tablets (Initial posting – 6/29/2012)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

Sandoz Customer Service:
1-609-627-8500

25 mg, 100s (NDC 0781-1072-01)
Available
N/A Shortage of an active ingredient
Reverified 4/16/2013
25 mg, 1000s (NDC 0781-1072-10)
50 mg, 100s (NDC 0781-1071-01)
50 mg, 1000s (NDC 0781-1071-10)

Fera Pharmaceuticals Customer Service
1-414-434-6604

25 mg, 100s (NDC 48102-0100-01)
Ample supply to meet the national market demand. Shortage per Manufacturer:
Available
Other Reverified 1/18/2013
50 mg, 100s (NDC 48102-0101-01)
Neptazane- 25 mg, 90s (NDC 48102-0014-90)
Neptazane- 50 mg, 90s (NDC 48102-0015-90)

 

Methoxsalen 1% topical lotion (Oxsoralen)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Valeant Pharmaceuticals International
1-866-819-9007
  

There is not yet an estimated release date.

Shortage per Manufacturer:
Manufacturing delays

 OtherReverified 7/6/2010 

 

Methyldopate Hydrochloride Injection

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated

American Regent, Inc./Luitpold:

1-800-645-1706

50 mg/mL, 5 mL vial, 10s (NDC 00517-8905-10)UnavailableShortage per Manufacturer: American Regent is currently not releasing Methyldopate HCl Injection, USP.Shortage of active ingredientReverified 5/7/2013

 

Methylphenidate Hydrochloride Tablets (Initial Posting Date – 2/19/2013)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Mallinckrodt Customer Service:
1-800-325-8888
5 mg IR tablets (NDC 00406-1142-10)
 
Product temporairily unavailable.Shortage per Manufacturer: Shortage of active ingredient.Shortage of active ingredientReverified 4/19/2013 
10 mg IR tablets (NDC 00406-1144-01 and 00406-1144-10)
 
20 mg IR tablets (NDC 00406-1146-01 and 00406-1146-10)
 

 

Methylphenidate Hydrochloride ER Tablets (Initial Posting Date – 2/19/2013)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Mallinckrodt Customer Service:
1-800-325-8888
10 mg ER tablets (NDC 00406-1445-01) Limited availability through Spring 2013.Shortage per Manufacturer: Shortage of active ingredient.Shortage of active ingredientReverified 4/19/2013 
20 mg ER tablets (NDC 00406-1473-01)
 
Product temporarily unavailable.

 

Methylin Chewable Tablets (Initial Posting Date – 2/19/2013)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Shionogi Pharma, Inc.:
1-800-461-3696
2.5 mg tablets (NDC 59630-760-10)Product temporairily unavailable.Shortage per Manufacturer: Manufacturing issues.OtherReverified 4/19/2013 
5 mg tablets (NDC 59630-761-10) 
10 mg tablets (NDC 59630-762-10) 

 

Metoclopramide (Reglan) Injection

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Hospira Inc. Customer Service:
1-877-946-7747
5 mg/mL 2 mL vials (NDC 00409-3414-01)

Available

Please check with your wholesaler for available inventory.


Shortage per manufacturer: Available

OtherRevised 5/3/2013
Teva Pharmaceuticals
1-800-545-8800
5 mg/mL, 2 mL vial, 25 count (NDC 00703-4502-04)Teva has made the decision to re-introduce Metoclopramide to the market.  We expect availability by Q3 2013. Demand increase for the drug.

Reverified 4/15/2013

 

Midazolam Hydrochloride (Versed) Injection

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
APP
1-888-386-1300
1 mg/mL, 2 mL vial, 25 count (NDC 63323-0411-12)Available.  Check wholesalers for inventory.

Check with wholesalers for inventory.

Shortage per Manufacturer:
Increased demand

Demand increase for the drug.

Revised 4/30/2013

1 mg/mL, 5 mL vial, 25 count (NDC 63323-0411-25)Available.  Check wholesalers for inventory.
1 mg/mL, 10 mL vial, 10 count (NDC 63323-0411-10)Available.  Check wholesalers for inventory.
5 mg/mL, 5 mL vial, 10 count (NDC 63323-0412-05)Available.  Check wholesalers for inventory.
5 mg/mL, 10 mL vial, 10 count (NDC 63323-0412-10)Backordered.  Next release expected June 2013.
5 mg/mL, 2 mL vial, 25 count (NDC 63323-0412-02)Available.  Check wholesalers for inventory.
5 mg/mL, 1 mL fill in 2 mL vial, 25 count (NDC 63323-0412-25)Available.  Check wholesalers for inventory.
Bedford
Customer Service:
1-800-562-4797
1 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0137-02)Bedford has all midazolam presentations on back order and the company cannot estimate a release date.

The 1 mg/mL 2 mL and 10 mL vials and the 5 mg/mL 2 mL (1 mL fill), 5 mL and 10 mL vials are pending release while the other presentations will not be manufactured until capacity permits.

 

Bedford Laboratories has temporarily suspended the distribution of Ben Venue Laboratories manufactured products.  Availability of products is updated on the Bedford Laboratories website disclaimer icon

Shortage per Manufacturer:
Temporary suspension of manufacturing.

Discontinuation of the manufacture of the drug. 
1 mg/mL, 5 mL preservative-free vial, 10 count (NDC 55390-0137-05)
1 mg/mL, 10 mL vial, 10 count (NDC 55390-0125-10)
5 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0138-02)
5 mg/mL, 1 mL preservative-free, in 2 mL vial, 10 count (NDC 55390-0138-01)
5 mg/mL, 5 mL vial, 10 count (NDC 55390-0126-05)
5 mg/mL, 10 mL vial, 10 count (NDC 55390-0126-10)5 mg/mL, 10 mL vial, 10 count (NDC 55390-0126-10)
Hospira, Inc.
Customer Service:
1-877-946-7747
1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 0409-2306-62)Available

Hospira discontinued the following products:
1 mg/mL, 2 mL iSecure syringe (NDC 0409-2306-22)
5 mg/mL, 1 mL preservative-free iSecure syringe (NDC 0409-2307-21).

 

Shortage per Manufacturer:
Available/Other manufacturer/withdrawal

Demand increase for the drug/Other

Revised
5/3/2013
1 mg/mL, 2 mL preservative-free vial (NDC 0409-2305-17)

Next delivery May.

Estimated recovery 3Q 2013

1 mg/mL, 5 mL preservative-free vial (NDC 0409-2305-05)

Next delivery April.

Estimated recovery 2Q 2013

1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 0409-2306-12)Available
1 mg/mL, 10 mL vial (NDC 0409-2587-05)Available
1 mg/ml, 10 mL vial (NDC 0409-2587-05)

Next delivery April

Estimated recovery 2Q 2013 

5 mg/mL, 1 mL preservative-free vial (NDC 0409-2308-01)Available
5 mg/mL, 5 mL vial (NDC 0409-2596-03)Next delivery April
Estimated recovery 2Q 2013
 
5 mg/mL, 10 mL vial (NDC 0409-2596-05)Next delivery April
Estimated recovery 2Q 2013
 
5 mg/mL, 1 mL preservative-free Luer-Lock syringe (NDC 0409-2307-60)

Next delivery late April

Estimated recovery 2Q 2013

5 mg/mL, 2 mL preservative-free vial (NDC 0409-2308-02)Available

Sun Pharma USA (Caraco Pharmaceutical Laboratories, Ltd.)              Customer Service:         1-800-818-4555

2mg/2mL (1mg/mL)  NDC: 57664-0633-43, 10 packReadily Available
 

Product Available

Demand increase for the drug.

Posted 9/14/2012 
25mg/5mL (5mg/mL) NDC: 57664-0634-44, 10 pack
50mg/10mL (5mg/mL) NDC: 57664-0634-45, 10 pack
West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174
 

2 mL vial, 1 mg/mL

(NDC 0641-6057-25)25 pack

(NDC 0641-6057-10)10 pack

West-Ward currently has limited quantities available.
 


There is a backorder situation on the 1 mg/mL, 2 mL vail (25 pack).
 


West-Ward has accelerated production on all Midazolam product codes.
 

West-Ward is anticipating having additional lots of inventory available by the end of March 2013.


Product will be made available as it is released.
 

Demand increase for the drug.

Revised 2/11/2013

5 mL vial, 1 mg/mL

(NDC 0641-6059-10)

10 mL vial, 1 mg/mL
(NDC 0641-6056-10)

1 mL vial, 5 mg/mL

(NDC  0641-6061-25)25 pack(NDC  0641-6061-10)10 pack

2 mL vial, 5 mg/mL

(NDC  0641-6063-25)25 pack

(NDC  0641-6063-10)10 pack

10 mL vial, 5 mg/mL

(NDC 0641-6060-10)



 
Akorn:
1-800-932-5676
1 mg / mL; (2 mL x 10 pack)
(NDC 17478-0523-02)

Readily available

 
 NA NA

Reverified 4/3/2013

1 mg / mL;  (5 mL x 25 pack)
(NDC 17478-0523-55)
Readily available
1 mg / mL; (10 mL x 10 pack)
(NDC 17478-0523-10)
Readily available
5 mg / mL; (1 mL x 10 pack)
(NDC 17478-0524-01)
5 mg / mL; (2 mL x 10 pack)
(NDC 17478-0524-02)
5 mg / mL; (5 mL x 10 pack)
(NDC 17478-0524-05)
5 mg / mL; (10 mL x 10 pack)
(NDC 17478-0524-10)
Sagent Pharmaceuticals, Inc.
1-866-625-1618
2 mg/2 mL vial (preservative-free), NDC 25021-655-02AvailableShortage per Manufacturer:
Product Available
Demand increase for the drug.

Reverified 5/13/2013

5 mg/5 mL vial, (preservative-free) NDC 25021-655-05Allocation
5 mg/mL vial, (preservative-free) NDC 25021-656-01Allocation
10 mg/2 mL vial, (preservative-free) NDC 25021-656-02Available
10 mg/10 mL vial, NDC 25021-660-10On allocation
25 mg/5 mL vial, NDC 25021-661-05On allocation
50 mg/10 mL vial, NDC 25021-661-10Available

 

Morphine Sulfate Injection

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Hospira Inc. Customer Service:
1-877-946-7747
 
1 mg/mL, 30 mL PCA vial (NDC 0409-2029-02) 

Next delivery late May.

Estimated recovery: 2Q 2013
 

Please check with your wholesaler for available inventory.
 
Shortage per Manufacturer:
Manufacturing delay/Available
 

 OtherRevised 5/3/2013
5 mg/mL; 30 mL PCA vial (NDC 0409-6028-04)Available
 
50 mg/mL, 20 mL vial (NDC 0409-1134-03)

Next delivery June

Estimated recovery: 2Q 2013

50 mg/mL, 50 mL vial (NDC 0409-1134-05)Available
25 mg/mL; 4 mL Add-vantage vial (NDC 0409-6177-14)Next delivery late May
Estimated recovery: 2Q 2013
25 mg/mL, 10 mL Add-Vantage vial (NDC 0409-6179-14)
 

Next delivery June

Estimated recovery: 2Q 2013 

Amphastar Pharmaceuticals Inc.
Customer Service:
1-800-423-4136
1mg/mL, 30mL PCA Vial (NDC 0548-1911-25)






 

Amphastar will regularly release products.

Amphastar is experiencing a product shortage due to an increase in product demand caused by market supply issues. 

Demand increase for the drug.

Reverifed 5/13/2013
West-Ward Pharmaceuticals Customer Service:
1-800-631-2174
 

1 mL vial, 5 mg/mL
(NDC 0641-6073-25)

Available in limited quantities 

West-Ward has accelerated production on all Morphine codes and is projecting to have additional inventory available for release in the February-March 2013 timeframe.

Product will be made available as it is released

 

Demand increase for the drug.Revised 2/11/2013

1 mL vial, 8 mg/mL
(NDC 0641-6075-25)

Backordered
 

1 mL vial, 10 mg/mL)
(NDC 0641-6070-25)

Backordered
 

10mL vial, 10 mg/mL
(NDC 0641-6068-01)

Backordered
 

1 mL vial, 15 mg/mL
(NDC 0641-6071-25)
Backordered
 
20 mL vial, 15 mg/mL
(NDC 0641-6072-01)

Backordered
 

 

Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
APP
1-888-386-1300
Astramorph (preservative-free) Inj
0.5 mg/mL 2 mL ampule, 10 count (NDC 63323-0291-80)
 
APP has preservative-free Astramorph 0.5 mg/mL 2 mL ampules, 1 mg/mL 2 mL ampules and 10 mL ampules, and 0.5 mg/mL 10 mL vials on back order with an estimated release timing TBD.

Shortage per Manufacturer:
Manufacturing delay

 OtherReverified 4/30/2013
0.5 mg/mL 10 mL vial, 5 count (NDC 63323-0291-10)
1 mg/mL 2 mL ampule, 10 count (NDC 63323-0292-80)
1 mg/mL, 10 mL vial (NDC 63323-0292-10)
Hospira, Inc.
Customer Service:
1-877-946-7747
0.5 mg/mL; 10 mL vial (NDC 0409-3814-12) 

Next delivery late June.

Estimated recovery 2Q 2013

Shortage per manufacturer: Manufacturing delay.

Other

Revised 5/3/2013
1 mg/mL; 10 mL vial (NDC 0409-3815-12)

Next delivery early June.

Estimated recovery 2Q 2013

25 mg/mL; 1 mL vial (NDC 0409-1135-02)

Next delivery June

Estimated recovery 2Q 2013
 

2mg/mL; 1mL Carpuject (NDC0409-1890-01

Available

New preservative-free product to replace preserved product NDC 0409-1762-30
4mg/mL; 1mL Carpuject (NDC 0409-1891-01)

Available

New preservative-free product to replace preserved product NDC 0409-1258-30
8mg/mL; 1mL Carpuject (NDC 0409-1892-01)AvailableNew preservative-free product to replace preserved product NDC 0409-1260-69
10mg/mL; 1mL Carpuject (NDC 0409-1893-01)

Available

New preservative-free product to replace preserved product NDC 0409-1261-30
15mg/mL; 1mL Carpuject (NDC 0409-1894-01)AvailableNew preservative-free product to replace preserved product NDC 0409-1264-31
West-Ward Pharmaceuticals Customer Service:
1-800-631-2174
 

Infumorph
20 mL ampul, 10 mg/mL
(NDC 0641-6039-01)

West-Ward is currently experiencing a backorder situation on all presentations.


West-Ward has accelerated production on this product.
 

West-Ward is anticipating having product available by the end of March 2013.


Product will be made available as it is released.
 

Demand increase for the drug.Revised 2/11/2013

Infumorph
20 mL ampul, 25 mg/mL
(NDC 0641-6040-01)

Duramorph
10 mL ampul, 1 mg/mL)
(NDC 0641-6019-10)

Duramorph
10mL ampul, 0.5 mg/mL
(NDC 0641-6020-10)

 

Multi-Vitamin Infusion (Adult and pediatric)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Hospira , Inc.
Customer Service
1-877-946-7747
MVI-12 Adult; 10 mL vial (NDC 61703-423-81)Adult formulations:  temporarily suspended production.
 

Shortage per Manufacturer:
Adult formulations temporarily suspended production.

 

Shortage per Manufacturer:
Pediatric formulation-manufacturing issue.

Discontinuation of the manufacture of the drug.Reverified 4/29/2013
MVI-12 Adult; 2x50 mL PBP(NDC 61703-423-83)
MVI Adult; 10 mL vial (NDC 61703-422-81)
MVI Adult; 2x5 mL (NDC 61703-422-82)
MVI Adult 2x50 mL PBP (NDC 61703-422-83)
MVI Pediatric; 5 mL vial (NDC 61703-421-53)

Available

Baxter (Infuvite adult and pediatric IV solution)
Customer Service:
1-888-229-0001

INFUVITE Pediatric, Multiple Vitamins for Injection. Single Dose package. (NDC 54643-5646-1)

Baxter is the distributor of INFUVITE Multi Vitamins. Baxter has these multi-vitamin products on allocation and is working with the manufacturer to maximize the availability of INFUVITE Multi Vitamins.

 

Allocated availability through Sept. 2013.

For detailed clinical recommendations to use during this shortage, please see information posted by the American Society of Parenteral and Enteral Nutrition disclaimer icon 

Requirements related to complying with good manufacturing practices.Reverified 5/7/2013
INFUVITE Adult, Multiple Vitamins for Injection. Single dose package. (NDC 54643-5649-1)
INFUVITE Adult, Multiple Vitamins for Injection. Bulk package. (NDC 54643-5649-2)
INFUVITE Pediatric, Multiple Vitamins for Injection. Bulk package. (NDC 54643-5647-0)

 

Nalbuphine HCl (Nubain) Injection (Initial Posting - 5/15/2012)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Hospira Inc.
Customer Service:
1-877-946-7747
10 mg/mL; 1 mL ampule (NDC 0409-1463-01)

Next delivery July
Estimated recovery 3Q 2013
 

Please check with your wholesaler for available inventory.

Shortage per Manufacturer:
Manufacturing delay/Available

Other Revised 5/3/2013
10 mg/mL; 10 mL vial (NDC 0409-1464-01)

Next delivery May

Estimated recovery 2Q 2013

20 mg/mL; 1 mL ampule (NDC 0409-1465-01)

Next delivery July
Estimated recovery 3Q 2013

20 mg/mL; 10 mL vial (NDC 0409-1467-01)

Next delivery May

Estimated recovery 2Q 2013

 

Naloxone (Narcan) Injection (Initial Posting Date) - 2/22/2012 

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Hospira Inc.
Customer Service:
1-877-946-7747
Naloxone 0.4 mg/mL Injection; 1mL vial (NDC 00409-1215-01)

Available

Please check with your wholesaler for available inventory.

 

Shortage per Manufacturer manufacturing delay/Available

Other

Revised 5/3/2013
Naloxone 0.4 mg/mL Injection; 10mL MDV (NDC 00409-1219-01)

Next delivery May.

Estimated recovery 2Q 2013

Naloxone 0.4 mg/mL Injection; 1mL in 2mL Carpuject (NDC 00409-1782-69)

Available

Amphastar Pharmaceuticals, Inc.
1-800-423-4136
1mg/mL, 2mL Prefilled Syringe with needles (NDC 76329-1469-5)Available  N/AReverified 5/13/2013
1mg/mL, 2mL Prefilled Syringe without needles (NDC 76329-3369-1)

 

Neostigmine Methylsulfate Injection, USP (Initial Posting - 1/14/2012)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
APP
Customer Service 1-888-386-1300
0.5 mg/mL,  5 mg/10 mL MDV (NDC # 63323-382-10)Backordered. Next release anticipated May 2013. Check wholesaler for inventory. 

Increase in demand.

Reverified 4/30/2013 

1 mg/mL, 10 mg/10 mL MDV

(NDC # 63323-383-10)
 

Back-ordered. Check wholesaler inventory.      
Next release anticipated May 2013
 
American Regent/Luitpold
1-800-645-1706

1 mg/mL, 10 mL vial, package of 25 (NDC 00517-0033-25)

 Available

American Regent is currently releasing Neostigmine Methylsulfate Injection 1 mg/mL

Other

Reverified 5/7/2013

0.5 mg/mL, 10 mL vial, package of 25 (NDC 00517-0034-25)

Unavailable

American Regent is currently not releasing Neostigmine Methylsulfate Injection 0.5 mg/mL

West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174

Neostigmine Methylsulfate Injection, USP

0.5 mg/mL, 10 mL vial (NDC 0641-6076-10)

1  mg/mL, 10 mL
vial (NDC 0641-6077-10)

West-Ward currently has limited quantities available of both presentations

West-Ward has accelerated production on this product. 

West-Ward is anticipating having product available by the end of February 2013.

Product will be made available as it is released.

Demand increase for the drug.

Revised 2/11/2013 

 

 Nitroglycerin Ointment USP, 2% (Nitro-Bid) (Initial posting - 10/23/2012)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Savage Laboratories, A division of Fougera Pharmaceuticals Inc.
1-800-645-9833

Nitro-Bid
(Nitroglycerin Ointment USP, 2%); 1 g foilpac (NDC 0281-0326-08)

BackorderShortage per manufacturer:  Manufacturing delays 

Other

Revised  5/15/2013 

Nitro-Bid
(Nitroglycerin Ointment USP, 2%); 30 g tube (NDC 0281-0326-30)

Product now available; next release early June
 
  Demand increase for the drug 
Nitro-Bid
(Nitroglycerin Ointment USP, 2%); 60 g tube (NDC 0281-0326-60)
Product now available Demand increase for the drug 

 

Norethindrone and Ethinyl Estradiol Tablets, USP (Ovcon 50 Tablets) (Initial Posting -4/6/2012)

CompanyProductAvailability and Estimated Shortage DurationRelated InformationShortage Reason
(per New Legislation-FDASIA)*
Date Updated
Warner Chilcott
Customer Service
1-877-597-9462
28x6 (NDC 0430-0585-14)No estimated date of availability.Shortage per Manufacturer:
Manufacturing delays
 Other 
28x3 (NDC 0430-0585-45)

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Current Drug Shortages Index

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