Drug product
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
D-1416-2012
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 62405
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 949 Cases, b) 188 bottles
- Official record key
drug-enforcement:D-1416-2012
Official wording
Reason: Impurities/Degradation Products: exceeded specification at 3 month stability testing
Code information: Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Impurities/Degradation Products: exceeded specification at 3 month stability testing