Drug product
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
D-1082-2019
Product summary
- Event
- Event 82483
- Status
- Terminated
- Classification
- Class III
- Quantity
- 167 vials
- Official record key
drug-enforcement:D-1082-2019
Official wording
Reason: Failed pH Specification: product does not meet pH label claim.
Code information: Lot 190205@1, expiry 08/4/19
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Failed pH Specification: product does not meet pH label claim.