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  4. Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA
Company Name:
Amneal Pharmaceuticals, LLC
Brand Name:
Brand Name(s)
Amneal
Product Description:
Product Description
Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

Company Announcement

FOR IMMEDIATE RELEASE – Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.

Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP), manufactured by Amneal, are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) subject to the recall can be identified by NDC numbers stated on the product label:

Product Strength Pack Size NDC Number
Ranitidine Tablets, USP 150 mg 60 count 65162-253-06
Ranitidine Tablets, USP 150 mg 100 count 65162-253-10
Ranitidine Tablets, USP 150 mg 180 count 65162-253-18
Ranitidine Tablets, USP 150 mg 500 count 65162-253-50
Ranitidine Tablets, USP 150 mg 1000 count 65162-253-11
Ranitidine Tablets, USP 150 mg 1000 count 53746-253-10
Ranitidine Tablets, USP 300 mg 30 count 65162-254-03
Ranitidine Tablets, USP 300 mg 100 count 65162-254-10
Ranitidine Tablets, USP 300 mg 250 count 65162-254-25
Ranitidine Tablets, USP 300 mg 250 count 53746-254-02
Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL;
6 fl. oz.
473 mL 65162-664-90

The affected Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) were distributed directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST to arrange for product return.

Consumers who have Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) which are being recalled should stop using the product and can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

The following lot numbers of Ranitidine Tablets, USP, 150 mg & 300 mg and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL are included in this recall.  

Ranitidine Tablets, USP, 150mg

NDC No. Description Lot Expiration Date
53746-253-10 Ranitidine Tablets, USP 150mg HB03718A 3/2020
53746-253-10 Ranitidine Tablets, USP 150mg HB03818A 3/2020
53746-253-10 Ranitidine Tablets, USP 150mg HB03918A 3/2020
53746-253-10 Ranitidine Tablets, USP 150mg HB04018A 3/2020
53746-253-10 Ranitidine Tablets, USP 150mg HC01618A 3/2020
53746-253-10 Ranitidine Tablets, USP 150mg HC14618A 5/2020
53746-253-10 Ranitidine Tablets, USP 150mg HC14718A 5/2020
53746-253-10 Ranitidine Tablets, USP 150mg HC14818A 5/2020
53746-253-10 Ranitidine Tablets, USP 150mg HC14918A 5/2020
53746-253-10 Ranitidine Tablets, USP 150mg HC15018A 5/2020
53746-253-10 Ranitidine Tablets, USP 150mg HK02318A 9/2020
53746-253-10 Ranitidine Tablets, USP 150mg HK02418A 9/2020
53746-253-10 Ranitidine Tablets, USP 150mg HK02518A 9/2020
53746-253-10 Ranitidine Tablets, USP 150mg HK02618A 9/2020
53746-253-10 Ranitidine Tablets, USP 150mg HD03119A 3/2021
53746-253-10 Ranitidine Tablets, USP 150mg HD03219A 3/2021
53746-253-10 Ranitidine Tablets, USP 150mg HE03119A 4/2021
53746-253-10 Ranitidine Tablets, USP 150mg HE03219A 4/2021

 

NDC No. Description Lot Expiration Date
65162-253-06 Ranitidine Tablets, USP 150mg AR171764A 11/2019
65162-253-06 Ranitidine Tablets, USP 150mg AR171875A 11/2019
65162-253-06 Ranitidine Tablets, USP 150mg AR171876A 11/2019
65162-253-06 Ranitidine Tablets, USP 150mg AR171981A 11/2019
65162-253-06 Ranitidine Tablets, USP 150mg AR180020C 1/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180206A 1/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180207A 1/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180208A 1/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180438A 2/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180439A 2/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180481A 3/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180482A 3/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR180483A 3/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR181690A 10/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR181691A 10/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR181806A 11/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR190058A 12/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR190059A 12/2020
65162-253-06 Ranitidine Tablets, USP 150mg AR190183A 1/2021
65162-253-06 Ranitidine Tablets, USP 150mg AR190184A 1/2021

 

NDC No. Description Lot Expiration Date
65162-253-10 Ranitidine Tablets, USP 150mg AR171984A 12/2019
65162-253-10 Ranitidine Tablets, USP 150mg AR180020B 1/2020
65162-253-10 Ranitidine Tablets, USP 150mg AR180675A 4/2020
65162-253-10 Ranitidine Tablets, USP 150mg AR180868B 5/2020
65162-253-10 Ranitidine Tablets, USP 150mg AR181807A 11/2020
65162-253-10 Ranitidine Tablets, USP 150mg AR190366B 2/2021

 

NDC No. Description Lot Expiration Date
65162-253-11 Ranitidine Tablets, USP 150mg AR171986A 12/2019
65162-253-11 Ranitidine Tablets, USP 150mg AR171987A 12/2019
65162-253-11 Ranitidine Tablets, USP 150mg AR180255A 1/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180441A 2/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180442A 2/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180559A 3/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180560A 3/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180594A 3/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180595A 3/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180829A 4/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180831A 5/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180832A 5/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR180868A 5/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR181807C 11/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR190085A 12/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR190086A 12/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR190087A 12/2020
65162-253-11 Ranitidine Tablets, USP 150mg AR190124A 1/2021
65162-253-11 Ranitidine Tablets, USP 150mg AR190542B 3/2021
65162-253-11 Ranitidine Tablets, USP 150mg AR190609A 3/2021
65162-253-11 Ranitidine Tablets, USP 150mg AR190610A 3/2021

 

NDC No. Description Lot Expiration Date
65162-253-18 Ranitidine Tablets, USP 150mg AR171875B 11/2019
65162-253-18 Ranitidine Tablets, USP 150mg AR180483B 3/2020
65162-253-18 Ranitidine Tablets, USP 150mg AR181807B 11/2020
65162-253-18 Ranitidine Tablets, USP 150mg AR190008B 12/2020

 

NDC No. Description Lot Expiration Date
65162-253-50 Ranitidine Tablets, USP 150mg AR171763A 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171764B 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171874A 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171875C 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171877B 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171878B 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171982A 11/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171983A 12/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR171985A 12/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR180016A 12/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR180017A 12/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR180018A 12/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR180019A 12/2019
65162-253-50 Ranitidine Tablets, USP 150mg AR180020A 1/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180208B 1/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180256A 1/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180291A 1/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180292A 1/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180293A 1/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180294A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180295A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180364A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180365A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180366A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180367A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180368A 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180440B 2/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180484A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180485A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180556A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180557A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180558A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180596A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180597A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180598A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180599A 3/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180675B 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180676A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180677A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180678A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180679A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180801A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180802A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180803A 4/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180869A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180870A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180871A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180872A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180994A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180995A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180996A 5/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180997A 6/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR180998A 6/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181158A 7/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181159A 7/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181160A 7/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181161A 7/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181692A 10/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181693A 10/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181694A 10/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181709A 10/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181710A 11/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181711A 11/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181808A 11/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR181809A 11/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190004A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190005A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190006A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190007A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190008A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190088A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190089A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190090A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190121A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190122A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190123A 12/2020
65162-253-50 Ranitidine Tablets, USP 150mg AR190125B 1/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190181A 1/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190182A 1/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190364A 2/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190365A 2/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190366A 2/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190509A 3/2021
65162-253-50 Ranitidine Tablets, USP 150mg AR190510A 3/2021

 

Ranitidine Tablets, USP, 300mg

NDC No. Description Lot Expiration Date
53746-254-02 Ranitidine Tablets, USP 300mg HB04118A 2/2020
53746-254-02 Ranitidine Tablets, USP 300mg HB04218A 2/2020
53746-254-02 Ranitidine Tablets, USP 300mg HB04318A 2/2020
53746-254-02 Ranitidine Tablets, USP 300mg HB04418A 2/2020
53746-254-02 Ranitidine Tablets, USP 300mg HF13518A 6/2020
53746-254-02 Ranitidine Tablets, USP 300mg HF13618A 6/2020
53746-254-02 Ranitidine Tablets, USP 300mg HF13718A 6/2020
53746-254-02 Ranitidine Tablets, USP 300mg HF13818A 6/2020
53746-254-02 Ranitidine Tablets, USP 300mg HK02818A 9/2020
53746-254-02 Ranitidine Tablets, USP 300mg HK02918A 9/2020
53746-254-02 Ranitidine Tablets, USP 300mg HK03018A 9/2020
53746-254-02 Ranitidine Tablets, USP 300mg HK03118A 9/2020
53746-254-02 Ranitidine Tablets, USP 300mg HL08418A 11/2020
53746-254-02 Ranitidine Tablets, USP 300mg HL08518A 11/2020
53746-254-02 Ranitidine Tablets, USP 300mg HL08618A 11/2020
53746-254-02 Ranitidine Tablets, USP 300mg HL08718A 11/2020
53746-254-02 Ranitidine Tablets, USP 300mg HB01419A 1/2021
53746-254-02 Ranitidine Tablets, USP 300mg HB05619A 1/2021
53746-254-02 Ranitidine Tablets, USP 300mg HB05719A 1/2021
53746-254-02 Ranitidine Tablets, USP 300mg HB05819A 1/2021
53746-254-02 Ranitidine Tablets, USP 300mg HB05919A 1/2021
53746-254-02 Ranitidine Tablets, USP 300mg HB06019A 1/2021
53746-254-02 Ranitidine Tablets, USP 300mg HB06119A 1/2021

 

NDC No. Description Lot Expiration Date
65162-254-03 Ranitidine Tablets, USP 300mg AR172033B 11/2019
65162-254-03 Ranitidine Tablets, USP 300mg AR180024A 12/2019
65162-254-03 Ranitidine Tablets, USP 300mg AR180025A 12/2019
65162-254-03 Ranitidine Tablets, USP 300mg AR180118A 12/2019
65162-254-03 Ranitidine Tablets, USP 300mg AR180119A 12/2019
65162-254-03 Ranitidine Tablets, USP 300mg AR180519A 3/2020
65162-254-03 Ranitidine Tablets, USP 300mg AR180615A 3/2020
65162-254-03 Ranitidine Tablets, USP 300mg AR181795A 11/2020
65162-254-03 Ranitidine Tablets, USP 300mg AR181921B 12/2020
65162-254-03 Ranitidine Tablets, USP 300mg AR190705A 4/2021

 

NDC No. Description Lot Expiration Date
65162-254-10 Ranitidine Tablets, USP 300mg AR172029A 11/2019
65162-254-10 Ranitidine Tablets, USP 300mg AR172030A 11/2019
65162-254-10 Ranitidine Tablets, USP 300mg AR180021A 12/2019
65162-254-10 Ranitidine Tablets, USP 300mg AR180022A 12/2019
65162-254-10 Ranitidine Tablets, USP 300mg AR180023A 12/2019
65162-254-10 Ranitidine Tablets, USP 300mg AR180123A 12/2019
65162-254-10 Ranitidine Tablets, USP 300mg AR180144A 1/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180145A 1/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180146A 1/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180147A 1/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180402A 2/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180465A 2/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180466A 2/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180467A 2/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180468A 2/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR180613A 3/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR181156A 7/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR181157A 7/2020
65162-254-10 Ranitidine Tablets, USP 300mg AR190418B 2/2021

 

NDC No. Description Lot Expiration Date
65162-254-25 Ranitidine Tablets, USP 300mg AR171800A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171801A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171802A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171803A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171804A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171931A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171932A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171933A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171934A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171935A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171936A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR171937A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172026A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172027A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172028A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172031A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172032A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172033A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172034A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR172035A 11/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180030A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180031A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180032A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180033A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180034A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180113A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180114A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180115A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180117A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180120A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180121A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180122A 12/2019
65162-254-25 Ranitidine Tablets, USP 300mg AR180148A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180198A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180199A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180200A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180201A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180202A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180257A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180258A 1/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180335A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180336A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180337A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180338A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180339A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180374A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180375A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180376B 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180403A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180404A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180405A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180406A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180424A 2/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180486A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180487A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180488A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180515A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180516A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180517A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180518A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180638A 3/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180640A 4/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR180641A 4/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR181920A 12/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR181921A 12/2020
65162-254-25 Ranitidine Tablets, USP 300mg AR190414B 2/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190415A 2/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190416A 2/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190417A 2/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190418A 2/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190543A 3/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190544A 3/2021
65162-254-25 Ranitidine Tablets, USP 300mg AR190545A 3/2021

Ranitidine Syrup (Ranitidine Oral Solution, USP)

NDC No. Description Lot Expiration Date
65162-664-90 Ranitidine Syrup 15mg/mL 06648001A 11/2019
65162-664-90 Ranitidine Syrup 15mg/mL 06648003A 4/2020
65162-664-90 Ranitidine Syrup 15mg/mL 06649001A 1/2021

 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Safe Harbor Statement

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the “Company”). Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.


Company Contact Information

Consumers:
Stericycle
866-918-8768
Media:
Ms. Candis Edwards
Information@amneal.com

Product Photos

 
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