The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1113-2017·Announced 2017-08-30

C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 60 mg, due to a label mixup that may result in mislabeling.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk contamination.

Plain-English summary

C. O. Truxton is recalling Phenobarbital Tablets USP, 60 mg, 1000 count bottles. The recall is being conducted because of a labeling issue described as a label mixup, which means the products may be mislabeled.

The affected products are manufactured by West-ward Pharmaceutical Corp. in Eatontown, NJ, and distributed by Truxton, Inc. in Bellmawr, NJ. The specific lots involved are # 71416A (Exp. 05/20), # 70881A (Exp. 07/17), # H15A68 (Exp. 01/18), and # 70980A (Exp. 02/18). The NDC number for the product is 0463-6151-10.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or pharmacy for credit. Patients should consult their healthcare provider for alternative medication if necessary.

The recalled product

Product
Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
Manufacturer
C. O. Truxton
Category
Drug — Anticonvulsant
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot # 71416A
  • Exp. 05/20 Lot # 70881A
  • Exp. 07/17 Lot # H15A68
  • Exp. 01/18 Lot # 70980A
  • Exp. 02/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by C. O. Truxton under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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