Recalls / Class II
Class IID-1114-2017
Product
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
- Affected lot / code info
- a) Lot # 70989A; Exp. 02/18, Lot # 70973A; Exp. 01/18 b) Lot # 70973A; Exp. 01/18, Lot # H15A76; Exp. 02/18, Lot # 71346A; Exp. 12/19, Lot # 70989A; Exp. 02/18
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-1114-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.