Recalls / Class II
Class IID-0458-2017
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
- Affected lot / code info
- a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17)
Why it was recalled
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 32,027 bottles and 16,310 unit dose cups
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-18
- FDA classified
- 2017-02-02
- Posted by FDA
- 2017-02-08
- Terminated
- 2021-08-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0458-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.