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.
What this means for you
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
- cgmp-deviation
- manufacturing-defect
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.
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