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.
Reported: July 18, 2012 Initiated: May 30, 2012 #D-1416-2012
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.
Reason for Recall
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- a) 949 Cases, b) 188 bottles
- Distribution
- Nationwide
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by VistaPharm, Inc.. Units affected: a) 949 Cases, b) 188 bottles.
Why was this product recalled? ▼
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 18, 2012. Severity: Moderate. Recall number: D-1416-2012.
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