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
Reported: August 30, 2017 Initiated: April 20, 2017 #D-1111-2017
Product Description
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
Details
- Recalling Firm
- C. O. Truxton
- Units Affected
- unknown
- Distribution
- Nationwide
- Location
- Bellmawr, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by C. O. Truxton. Units affected: unknown.
Why was this product recalled? ▼
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 30, 2017. Severity: Critical. Recall number: D-1111-2017.
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