Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall – Labeling Error on Declared Strength
ISSUE: C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.
This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.
BACKGROUND: The product is indicated for use as a sedative or anticonvulsant and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 0463616010 6, lot number 70952A, expiration date 11/17. The 15 mg Tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30 mg Tablet is debossed with “West-ward 450” on one side and scored on the reverse side. The product was distributed Nationwide in the USA to Physician & Veterinarian Treatment Centers.
Read the MedWatch safety alert, including a link to the press release, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554358.htm