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Mislabeled Sedative Prompts Recall

August 31, 2017

A mislabeled bottle has prompted C.O. Truxton Inc. to voluntary recall more than a dozen lots of phenobarbital tablets, according to the August 30, 2017, US Food and Drug Administration (FDA) Enforcement Report.

“The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30-mg tablets,” the company stated in an announcement (April 21, 2017). “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.”

C.O. Truxton initiated the recall April 20, 2017. On August 22, 2017, the FDA designated the recall Class I—implying immediate danger of death or serious injury from use of the product—for the following formulations and lots:

  • phenobarbital tablets USP, 15 mg, 1000-count bottles (NDC 0463-6160-10), from lot 70952A (Exp. 11/17); and
  • phenobarbital tablets USP, 30 mg, 1000-count bottles (NDC 0463-6145-10), from lots 70926A (Exp. 11/17), 70981A (Exp. 1/18), and H15A59 (Exp. 8/18).

Other lots in the recall were designated Class II by the FDA, suggesting use could cause temporary or medically reversible consequences but that the probability of serious harm is remote. These include:

  • phenobarbital tablets USP, 60 mg, 1000-count bottles (NDC 0463-6151-10), from lots 71416A (Exp. 5/20), 70881A (Exp. 7/17), H15A68 (Exp. 1/18), and 70980A (Exp. 2/18);
  • phenobarbital tablets USP, 100 mg, 100-count bottles (NDC 0463-6152-01), from lots 70989A (Exp. 2/18) and 70973A (Exp. 1/18);
  • phenobarbital tablets USP, 100 mg, 1000-count bottles (NDC 0163-6152-10), from lots 70973A (Exp. 1/18), H15A76 (Exp. 2/18), 71346A (Exp. 12/19), and 70989A (Exp. 2/18); and
  • phenobarbital tablets USP, 15 mg, 1000-count bottles (NDC 0463-6160-10), from lots 71162A (Exp. 10/18), 70915A (Exp. 8/17), and H15A55 (Exp. 11/17).

The affected bottles were distributed to physicians and veterinary centers nationwide. The products were manufactured by West-Ward Pharmaceutical Corp.

Phenobarbital is a prescription medication indicated for use as a sedative or anticonvulsant.

Jolynn Tumolo

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