FDA-Drug2017-08-30Class I

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

C. O. Truxton
Hazard

Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

Sold states
Nationwide
Affected count
unknown
Manufactured in
136 Harding Ave, Bellmawr, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1111-2017

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