Status
Terminated
Drug Enforcement D-1416-2012
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Classification
Class II
Report Date
July 18, 2012
Termination Date
May 22, 2013
Product Information
- Product description
- 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.
- Product quantity
- a) 949 Cases, b) 188 bottles
- Reason for recall
- Impurities/Degradation Products: exceeded specification at 3 month stability testing
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- VistaPharm, Inc.
- Address
-
7265 Ulmerton Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1416-2012
- Event ID
- 62405
- Recall initiation date
- May 30, 2012
- Center classification date
- July 12, 2012
- Code info
- Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
- More code info
- —