Recalls / Class III
Class IIID-1139-2017
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
- Affected lot / code info
- Lot: 494700 Exp. 10/2018
Why it was recalled
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 3084 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-08-17
- FDA classified
- 2017-09-12
- Posted by FDA
- 2017-09-20
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1139-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.