FDA Recall D-1111-2017
C. O. Truxton · Bellmawr, NJ
Class I — life-threatening Terminated 509 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Recall record
- Recall number
D-1111-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2017-04-20
- Classified by FDA Center
- 2017-08-22
- FDA published
- 2017-08-30
- Terminated
- 2018-09-11
- Recalling firm
- C. O. Truxton
- Firm location
- Bellmawr, NJ