The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-1112-2017·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, 30 mg, because they may be mislabeled. The FDA classifies this as a Class I recall.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.

Plain-English summary

C. O. Truxton is recalling Phenobarbital Tablets USP, 30 mg, 1000 count bottles. The product is manufactured by West-ward Pharmaceutical Corp. and distributed by Truxton, Inc. The recall is due to a labeling error where the product may be mislabeled.

The FDA has classified this recall as Class I. The affected lots are # 70926A (Exp. 11/17), # 70981A (Exp. 01/18), and # H15A59 (Exp. 08/18). The NDC for the product is 0463-6145-10. The distribution pattern is listed as nationwide.

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 disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication if necessary.

The recalled product

Product
Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10
Manufacturer
C. O. Truxton
Category
Drug — Prescription Medication
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 (4)

  • Lot # 70926A
  • Exp. 11/17 Lot # 70981A
  • Exp. 01/18 Lot # H15A59
  • Exp. 08/18

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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