D-0008-2018 Class II Terminated
FDA drug recall D-0008-2018 was initiated by United Pharmacy on September 27, 2017 and is designated Class II. Reason for recall: CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed The recall status is terminated (terminated March 29, 2018). Affected quantity: 268 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 18, 2017
- Initiation Date
- September 27, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 268 vials
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
Reason for Recall
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Distribution Pattern
Nationwide.
Code Information
Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18