D-0854-2021 Class II Terminated
FDA drug recall D-0854-2021 was initiated by American Health Packaging on September 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. The recall status is terminated (terminated June 8, 2023). Affected quantity: 548 ccases.
Recall Details
- Product Type
- Drugs
- Report Date
- October 6, 2021
- Initiation Date
- September 15, 2021
- Termination Date
- June 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 548 ccases
Product Description
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
Reason for Recall
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Distribution Pattern
Nationwide USA
Code Information
Lot 1000082; Exp 06/30/2022