D-1416-2012 Class II Terminated
FDA drug recall D-1416-2012 was initiated by VistaPharm, Inc. on May 30, 2012 and is designated Class II. Reason for recall: Impurities/Degradation Products: exceeded specification at 3 month stability testing The recall status is terminated (terminated May 22, 2013). Affected quantity: a) 949 Cases, b) 188 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 18, 2012
- Initiation Date
- May 30, 2012
- Termination Date
- May 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 949 Cases, b) 188 bottles
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
Distribution Pattern
Nationwide
Code Information
Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1416-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026