United Pharmacy Recalls Compounded Glutamine Injection Vials Due to CGMP Deviations
United Pharmacy is recalling 268 vials of compounded Glutamine, Arginine, and Carnitine injection due to CGMP deviations and the absence of glutamine.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a compounded drug that lacks its active ingredient and contains unknown impurities, which poses a significant risk of harm.
Plain-English summary
United Pharmacy is recalling 268 vials of Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection. The product was compounded by United Pharmacy, located at 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417. The affected lots are GAC-12 with a best-use date of 11/10/17 and GAC-13 with a best-use date of 01/14/18. The product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA analysis determined that the product does not contain glutamine and that two unknown impurities were observed. The agency has classified this recall as Class II.
Healthcare providers and patients who have received this product should stop using it and contact United Pharmacy for further instructions. Consumers should not use the product and should return it to the pharmacy where it was obtained.
The recalled product
- Product
- Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
- Manufacturer
- United Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 268
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: GAC-12 BUD 11/10/17
- Lot: GAC-13 BUD: 01/14/18
Distribution
Distributed nationwide across the United States.
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