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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary
Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance

 

Contact
Consumer:
407-936-2998
877-306-0008
 

FOR IMMEDIATE RELEASE - April 17, 2013 - Balanced Solutions Compounding Pharmacy, LLC today announced a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control processes, which present a lack of sterility assurance.

Patients are at increased risk for infections in the event a sterile product is compromised. During a recent inspection the FDA sampled chromium chloride injection from Balanced Solutions Compounding Pharmacy and identified gram negative bacteria in the product, which Balanced Solutions Compounding Pharmacy, LLC had previously recalled. To date, Balanced Solutions Compounding Pharmacy, LLC has received no reports of injury or illness associated with the use of our sterile products. Patient safety is our highest priority and, out of an abundance of caution, we have decided to initiate this voluntary recall to include all lots of all sterile products within expiry. The affected products can be found at www.bshrx.com.

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were furnished nationwide. Balanced Solutions Compounding Pharmacy, LLC will be notifying customers by phone, fax and/or mail to return the products to the pharmacy. The sterile products include all injectables with the Balanced Solutions Compounding Pharmacy name.

Consumers or Health Care providers with questions regarding this recall may contact Balanced Solutions Compounding Pharmacy, LLC by phone at 407-936-2998 or 877-306-0008 from the hours of 9:30AM- 6:00PM Eastern Standard Time Monday-Friday or e-mail address at pharmacist@bshrx.com. Patients who have received any product furnished by Balanced Solutions Compounding Pharmacy and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of any Balanced Solutions Compounding Pharmacy products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

  • Fax: 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
     
Formula and Strength
Size
Units
Discard after
Date made
Units made
Distribution Dates
Amount Distributed
TRIMIX STANDARD (PGE STOCK SOLN) 30MG/0.5MG/10MCG INJECTABLE
10
ml
5/1/2013
10/29/2012
178
10/13/2012 to 4/12/13
178
METHYLPREDNISOLONE ACETATE 60MG/ML INJ SUSP
10
ml
7/1/2013
1/3/2013
176
10/13/2012 to 4/12/13
176
BETAMETHASONE 9 MG/ML INJECTABLE
10
ml
9/7/2013
3/12/2013
120
10/13/2012 to 4/12/13
120
SODIUM TRETRADECYL SULFATE 2% INJECTABLE
30
ml
6/18/2013
12/20/2012
60
10/13/2012 to 4/12/13
60
SODIUM TRETRADECYL SULFATE 1.5% INJECTABLE
30
ml
7/28/2013
1/29/2013
57
10/13/2012 to 4/12/13
45
SODIUM TRETRADECYL SULFATE 2% INJECTABLE
30
ml
5/30/2013
12/3/2012
30
10/13/2012 to 4/12/13
30
TRIAMCINOLONE HEXACETONIDE 20 MG/ML INJ SUSP
10
ml
6/17/2013
12/19/2012
32
10/13/2012 to 4/12/13
28
SODIUM TRETRADECYL SULFATE 0.15% INJECTABLE
30
ml
4/27/2013
10/29/2012
21
10/13/2012 to 4/12/13
21
SODIUM TRETRADECYL SULFATE 0.3% INJECTABLE
30
ml
7/27/2013
1/28/2013
20
10/13/2012 to 4/12/13
20
SODIUM TRETRADECYL SULFATE 5% INJECTABLE
30
ml
8/31/2013
3/5/2013
26
10/13/2012 to 4/12/13
20
CYANOCOBALAMIN (CMP) 1000MCG/ML INJECTABLE
30
ml
6/4/2013
3/6/2013
17
10/13/2012 to 4/12/13
15
METHYLCOBALAMIN 10 MG, FOLIC ACID 0.4 MG/ML 10MG/0.4MG/ML INJECTABLE
9
ml
4/29/2013
1/29/2013
18
10/13/2012 to 4/12/13
14
SODIUM TRETRADECYL SULFATE 2.2% INJECTABLE
30
ml
7/27/2013
1/28/2013
13
10/13/2012 to 4/12/13
10
SODIUM TRETRADECYL SULFATE 5% INJECTABLE
30
ml
8/31/2013
3/5/2013
56
10/13/2012 to 4/12/13
10
TRIMIX CUSTOM 20MG-1MG-7MCG INJECTABLE
5
ml
5/25/2013
11/27/2012
9
10/13/2012 to 4/12/13
9
PROGESTERONE - (OLIVE OIL) 100 MG/ML INJECTABLE
10
ml
4/28/2013
10/30/2012
8
10/13/2012 to 4/12/13
8
TRIMIX CUSTOM 30MG/2MG/20MCG INJECTABLE
10
ml
5/22/2013
2/21/2013
8
10/13/2012 to 4/12/13
7.5
METHYCLOBALAMIN 10 MG, FOLIC ACID 0.4 MG/ML (30ML) 10MG/0.4ML INJECTABLE
30
ml
4/22/2013
1/22/2013
7
10/13/2012 to 4/12/13
7
METHYCLOBALAMIN 10 MG, FOLIC ACID 0.4 MG/ML 10MG/0.4MG/ML INJECTABLE
9
ml
5/28/2013
2/27/2013
18
10/13/2012 to 4/12/13
7
CYCLOSPORIN (GRAPESEED OIL) 2% OPHTHALMIC
15
ml
7/6/2013
1/7/2013
6
10/13/2012 to 4/12/13
6
PHOSPHATIDYLCHOLINE 50MG/ML INJECTABLE
30
ml
4/29/2013
2/28/2013
5
10/13/2012 to 4/12/13
5
COMPREHENSIVE INJECTION #4 - SS VARIED INJECTABLE
30
ml
5/2/2013
1/9/2013
5
10/13/2012 to 4/12/13
5
MONO-MIX (PROSTAGLANDIN) 10MCG/ML INJECTABLE
10
ml
5/8/2013
2/7/2013
5
10/13/2012 to 4/12/13
5
MONO-MIX (PROSTAGLANDIN) 40MCG/ML INJECTABLE
10
ml
5/16/2013
11/19/2012
5
10/13/2012 to 4/12/13
5
CYCLOSPORIN (GRAPESEED OIL) 2% OPHTHLAMIC
15
ml
8/17/2013
2/8/2013
5
10/13/2012 to 4/12/13
5
MONO-MIX (PROSTAGLANDIN) 20MCG/ML INJECTABLE
10
ml
5/26/2013
2/6/2013
5
10/13/2012 to 4/12/13
5
TRIMIX CUSTOM 30MG/1MG/10MCG INJECTABLE
10
ml
4/21/2013
1/21/2013
3
10/13/2012 to 4/12/13
3
TRIMIX CUSTOM 30MG/1MG/20MCG/ML INJECTABLE
10
ml
4/30/2013
1/30/2013
3
10/13/2012 to 4/12/13
3
BIMIX STANDARD 30MG/0.5MG INJECTABLE
10
ml
5/7/2013
2/6/2013
3
10/13/2012 to 4/12/13
3
TRIMIX CUSTOM 30MG/1MG/20MCG/ML INJECTABLE
10
ml
5/14/2013
2/21/2013
3
10/13/2012 to 4/12/13
3
TRIMIX CUSTOM 30MG/1MG/20MCG/ML INJECTABLE
10
ml
6/2/2013
3/4/2013
3
10/13/2012 to 4/12/13
3
TRIMIX CUSTOM 30MG/1MG/20MCG/ML INJECTABLE
10
ml
6/11/2013
3/13/3013
3
10/13/2012 to 4/12/13
3
PROGESTERONE - (OLIVE OIL) 100 MC/ML INJECTABLE
10
ml
9/10/2013
3/14/2013
3
10/13/2012 to 4/12/13
3
TRIMIX CUSTOM 20MG-1MG-7MCG INJECTABLE
10
ml
5/25/2013
11/27/2012
3
10/13/2012 to 4/12/13
3
TRIMIX CUSTOM 20MG/1MG/3.5MCG INJECTABLE
5
ml
4/17/2013
1/17/2013
2
10/13/2012 to 4/12/13
2
BIMIX PLUS 30MG/1MG INJECTABLE
10
ml
4/23/2013
1/23/2012
2
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 40MG/1MG/50MCG INJECTABLE
10
ml
4/27/2013
10/23/2012
2
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 20MG/1.33MG/13.33MCG INJECTABLE
10
ml
5/8/2013
2/7/2013
2
10/13/2012 to 4/12/13
2
QUADMIX CUSTOM 30MG/1MG/0.1MG/10MCG INJECTABLE
10
ml
5/14/2013
2/13/2013
2
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM W/ CHLORPROMAZINE 12MG/1MG/12MCG INJECTABLE
10
ml
5/20/2013
2/19/2013
3
10/13/2012 to 4/12/13
2
17 ALPHA HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE
5
ml
5/28/2013
1/2/2013
2
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 30MG/4MG/40MCG INJECTABLE
10
ml
6/2/2013
3/4/2013
2
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 20MG/1MG/3.5MCG INJECTABLE
5
ml
6/3/2013
3/5/2013
3
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 40MG/1MG/20MCG INJECTABLE
10
ml
6/5/2013
3/7/2013
2
10/13/2012 to 4/12/13
2
QUADMIX 26MG/1MG/10MCG/0.1 INJECTABLE
10
ml
6/16/2013
2/5/2013
2
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 35MG/2MG/40MCG INJECTABLE
10
ml
5/26/2013
2/25/2013
2
10/13/2012 to 4/12/13
2
DMSO 50% STERILE BLADDER IRRIGATION SOLUTIUON 50% INJECTABLE
50
ml
7/16/2013
1/17/2013
10
10/13/2012 to 4/12/13
2
TRIMIX CUSTOM 40MG/1.5MG/30MCG INJECTABLE
10
ml
4/21/2013
1/21/2013
2
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 39MG/3MG/40MCG INJECTABLE
10
ml
4/23/2013
1/23/2013
2
10/13/2012 to 4/12/13
1
BIMIX PLUS 30MG/1MG INJECTABLE
5
ml
4/23/2013
1/23/2013
1
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 35/MG/2MG/20MCG INJECTABLE
10
ml
5/6/2013
2/5/2013
2
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 30MG/4MG/2.5MCG INJECTABLE
10
ml
5/12/2013
2/11/2013
2
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 30MG/1MG/5MCG INJECTABLE
10
ml
5/14/2013
2/20/2013
2
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 45MG/1MG/15MCG INJECTABLE
10
ml
5/15/2013
2/14/2013
1
10/13/2012 to 4/12/13
1
17ALPHA HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE
5
ml
5/28/2013
2/6/2013
2
10/13/2012 to 4/12/13
1
METHYLCOBALAMIN 1 MG/ML INJECTABLE
30
ml
6/2/2013
3/4/2013
1
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 30MG/1MG/10MCG INJECTABLE
10
ml
6/2/2013
3/4/2013
3
10/13/2012 to 4/12/13
1
QUADMIX CUSTOM 0.9MG/0.1MG/0.01MG/20MCG INJECTABLE
10
ml
6/3/2013
3/5/2013
2
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 30MG/2MG/10MCG
10
ml
41400
41310
1
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 22.5MG-0.83MG-8.3MCG INJECTABLE
10
ml
5/26/2013
2/25/2013
2
10/13/2012 to 4/12/13
1
CYCLOSPORIN (GRAPESEED OIL) 2% OPHTHLAMIC
15
ml
8/17/2013
2/18/2013
1
10/13/2012 to 4/12/13
1
BIMIX STANDARD 30MG/0.5MG INJECTABLE
5
ml
6/10/2013
3/12/2013
2
10/13/2012 to 4/12/13
1
TRIMIX CUSTOM 30MG-0.8MG-20MCG INJECTABLE
5
ml
6/12/2013
3/14/2013
2
10/13/2012 to 4/12/13
1
BACTERIOSTATIC WATER FOR INJECTION 0.9% INJECTABLE
10
ml
5/12/2013
11/13/2012
83
10/13/2012 to 4/12/13
0
CYANOCOBALAMIN (CMP) 1000MCG/ML INJECTABLE
10
ml
6/4/2013
3/6/2013
2
10/13/2012 to 4/12/13
0
TRIMIX STANDARD (PGE STOCK SOL'N) 30MG/0.5MG/10MCG INJECTABLE
5
ml
41453
2/19/2013
3
10/13/2012 to 4/12/13
0
METHYLPREDNISOLONE ACETATE 60MG/ML INJ SUSP
10
ml
8/11/2013
2/12/2013
169
10/13/2012 to 4/12/13
0
BETAMETHASONE 12 MG/ML INJECTABLE
10
ml
8/17/2013
2/18/2013
172
10/13/2012 to 4/12/13
0
BETAMETHASONE 12 MG/ML INJECTABLE
10
ml
9/1/2013
3/5/2013
170
10/13/2012 to 4/12/13
0
TRIMIX STANDARD (PGE STOCK SOL'N) 30MG/0.5MG/10MCG INJECTABLE
5
ml
6/28/2013
2/19/2013
3
10/13/2012 to 4/12/13
0
BETAMETHASONE 12 MG/ML INJECTABLE
10
ml
7/7/2013
1/8/2013
172
10/13/2012 to 4/12/13
172
TRIAMCINOLONE DIACETATE 40 MG/ML INJ SUSP
5
ml
8/5/2013
2/6/2013
172
10/13/2012 to 4/12/13
167
TRIMIX STANDARD (PGE STOCK SOL'N) 30MG/0.5MG/10MCG INJECTABLE
10
ml
6/2/2013
1/8/2013
172
10/13/2012 to 4/12/13
159
METHLPREDNISOLONE ACETATE 60MG/ML INJ SUSP
10
ml
8/4/2013
2/5/2013
172
10/13/2012 to 4/12/13
150
BETAMETHASONE 9 MG/ML INJECTABLE
10
ml
7/16/2013
1/17/2013
123
10/13/2012 to 4/12/13
109
TRIMIX STANDARD (PGE STOCK SOL'N) 30MG/0.5MG/10MCG INJECTABLE
10
ml
6/28/2012
2/19/2012
184
10/13/2012 to 4/12/13
43
SODIUM TETRADECYL SULFATE 1.5% INJECTABLE
30
ml
5/26/2013
11/27/2012
41
10/13/2012 to 4/12/13
40
SODIUM TETRADECYL SULFATE 5% INJECTABLE
30
ml
4/30/2013
11/14/2012
62
10/13/2012 to 4/12/13
30
TRIAMCINOLONE ACETONIDE 60 MG/ML INJ SUSP
10
ml
4/27/2013
10/29/2012
174
10/13/2012 to 4/12/13
18
TRIAMCINOLONE ACETONIDE 60 MG/ML INJ SUSP
30
ml
5/20/2013
2/19/2013
8
10/13/2012 to 4/12/13
5
COMPREHENSIVE INJECTION #4 - SS VARIED INJECTABLE
5
ml
9/2/2013
3/6/2013
157
10/13/2012 to 4/12/13
5
TRIAMCINOLONE DIACETATE 40 MG/ML INJ SUSP
10
ml
5/7/2013
11/8/2012
54
10/13/2012 to 4/12/13
1
HCG LYOPHYLIZED POWDER 10,000 UNITS/VIAL LYOPH. POWDE
30
ml
6/18/2013
12/20/2012
7
10/13/2012 to 4/12/13
5
SODIUM TETRADECYL SULFATE 0.3% INJECTABLE
10
ml
6/5/2013
3/7/2013
3
10/13/2012 to 4/12/13
2
BIMIX PLUS 30MG/1MG INJECTABLE
10
ml
5/8/2013
2/7/2013
2
10/13/2012 to 4/12/13
1
QUADMIX 20MG/3,G/40MCG/0.1MG INJECTABLE
5
ml
5/28/2013
1/22/2013
2
10/13/2012 to 4/12/13
1
17 ALPHA HYDROXYPROGESTERONE CARPROATE 250MG/ML INJECTABLE
10
ml
6/4/2013
2/6/2013
3
10/13/2012 to 4/12/13
1
BIMIX CUSTOM 25MG-0.83MG INJECTABLE
5
ml
6/5/2013
3/7/2013
3
10/13/2012 to 4/12/13
1
CYCLOSPORIN (CORN OIL) 1% OPHTHALMIC
15
ml
9/7/2013
3/11/2013
2
10/13/2012 to 4/12/13
1
QUADMIX 30MG/2MG/0.1MG/40MCG INJECTABLE
10
ml
6/2/2013
3/4/2013
2
10/13/2012 to 4/12/13
0

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