Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1114-2017·Announced 2017-08-30

Phenobarbital Tablets Recalled for Potential Labeling Errors

C. O. Truxton is recalling Phenobarbital Tablets USP, 100 mg, due to a label mixup that may result in mislabeled products.

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 the hazard is a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

C. O. Truxton is voluntarily recalling specific lots of Phenobarbital Tablets USP, 100 mg, in 100-count and 1000-count bottles. The recall is being conducted because of a labeling issue described as a label mixup, which means the products may be potentially mislabeled.

The affected products are manufactured by West-ward Pharmaceutical Corp. and distributed by Truxton, Inc. The recall covers specific lot numbers and expiration dates for both bottle sizes, as detailed in the product information. The distribution pattern for these products is nationwide.

Consumers and healthcare providers should check their inventory for the specific NDC numbers, lot numbers, and expiration dates listed in the recall notice. If the products match the recalled lots, they should be held and not dispensed or used until further instructions are provided by the recalling firm or the FDA.

The recalled product

Product: Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
Manufacturer: C. O. Truxton
Category: Drug — Prescription Medication
Hazard: mis-labeling

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 (9)

a) Lot # 70989A
Exp. 02/18
Lot # 70973A
Exp. 01/18 b) Lot # 70973A
Exp. 01/18
Lot # H15A76
Lot # 71346A
Exp. 12/19
Lot # 70989A

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 →

Same manufacturer · C. O. Truxton

See all →

Severe
C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
FDA (Drugs) · 2017-08-30
Critical
Phenobarbital Tablets Recalled Due to Incorrect Strength Labeling
FDA (Drugs) · 2017-08-30
Moderate
C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
FDA (Drugs) · 2017-08-30
Moderate
C. O. Truxton Recalls Mislabeled Amitriptyline HCL Tablets
FDA (Drugs) · 2017-08-30
Moderate
C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
FDA (Drugs) · 2017-08-30

Same hazard · mis labeling