Recalls / Class II
Class IID-1116-2017
Product
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
- Affected lot / code info
- Lot # 71162A; Exp. 10/18 Lot # 70915A; Exp. 08/17 Lot # H15A55; Exp. 11/17
Why it was recalled
Labeling: Label Mixup; potentially mislabeled
Recalling firm
- Firm
- C. O. Truxton
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 136 Harding Ave, Bellmawr, New Jersey 08031-2412
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-04-20
- FDA classified
- 2017-08-22
- Posted by FDA
- 2017-08-30
- Terminated
- 2018-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1116-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.