Why it was recalled
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Product description
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
Lot numbers, UPCs & expiration codes
Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0008-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2017
- FDA report date
- Oct 18, 2017
- Quantity
- 268 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- United Pharmacy
Original FDA data
Every field from FDA enforcement report D-0008-2018, exactly as published.
Show all FDA fields
- City
- West Palm Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78183
- Address
- 3951 Haverhill Rd N
- Code information
- Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18
- Postal code
- 33417-8154
- Report date
- Oct 18, 2017
- Product type
- Drugs
- Recall number
- D-0008-2018
- Classification
- Class II
- Recalling firm
- United Pharmacy
- Product quantity
- 268 vials
- Termination date
- Mar 29, 2018
- Reason for recall
- CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Sep 27, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 10, 2017