Recalls / Class II
Class IID-1416-2012
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.
- Affected lot / code info
- Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
Why it was recalled
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- a) 949 Cases, b) 188 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-05-30
- FDA classified
- 2012-07-12
- Posted by FDA
- 2012-07-18
- Terminated
- 2013-05-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1416-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.