Class II
Terminated
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.
- Company
- Vistapharm, Inc.
- Recall Initiated
- May 30, 2012
- Posted
- July 18, 2012
- Recall Number
- D-1416-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 949 Cases, b) 188 bottles
- Firm Location
- Largo, FL, United States
Reason for Recall
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Distribution
Nationwide
Lot / Code Info
Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
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