Recalls / Class I
Class ID-1111-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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 # 70952A; Exp. 11/17
Why it was recalled
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
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-1111-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.