The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0568-2022·Announced 2022-02-23

Pyrazinamide Tablets 500 mg Recalled Due to cGMP Deviations

ANI Pharmaceuticals, Inc. has recalled Pyrazinamide Tablets USP 500 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5,477 bottles distributed nationwide.

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 FDA classified this as Class II, and the source text identifies the reason as cGMP deviations without reporting any illnesses, injuries, or hospitalizations. This is a manufacturing process deviation without evidence of actual harm, consistent with a Moderate severity rating for FDA Class II recalls without reported adverse health outcomes.

Plain-English summary

ANI Pharmaceuticals, Inc. has voluntarily recalled Pyrazinamide Tablets, USP 500 mg, 100-count bottles (NDC 67253-660-10) manufactured by ULTRAtab Laboratories, Inc. in Highland, NY and distributed by Par Pharmaceuticals in Chestnut Ridge, NY. The recall was initiated on February 15, 2022, and classified by the FDA as Class II.

The recall reason is cGMP (current Good Manufacturing Practice) deviations. Lot #19B064A with an expiration date of March 2022 is affected. Approximately 5,477 bottles were distributed nationwide within the United States.

Consumers who have this product should contact their pharmacist or healthcare provider. The recall was voluntarily initiated by the firm and terminated on October 25, 2022.

The recalled product

Product
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
Manufacturer
ANI Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
5,477

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 (2)

  • Lot #: 19B064A
  • Exp. Date 03/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by ANI Pharmaceuticals, Inc. 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 5 products in this recall →

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