The Recall Desk
ModerateFDA (Drugs)·D-0578-2023·Announced 2023-05-24

Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation

RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.

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: FDA Class II recall with no reported illnesses or deaths. The recall addresses a manufacturing quality assurance program discontinuation, representing a theoretical risk rather than a confirmed product defect or contamination.

Plain-English summary

RemedyRepack Inc., located in Pennsylvania, is recalling Pyrazinamide 500 mg tablets in two packaging formats: 29 x 30-count cards (NDC 70518-2534-01, Lot B2110254-021423, expiration 08/17/2023) and 100-count unit-dose boxes (NDC 70518-2534-00, Lot J0684183-022323, expiration 02/28/2024). The product was originally manufactured by Akorn in Lake Forest, Illinois, and repackaged by RemedyRepack.

The recall was initiated because the original manufacturer discontinued the quality assurance program that would ensure the product meets its identity, strength, quality, and purity characteristics. This represents a manufacturing deviation from FDA Current Good Manufacturing Practice (CGMP) requirements.

The affected product was distributed to three direct customer accounts in Pennsylvania. Patients currently taking this medication should consult with their healthcare provider or pharmacist before discontinuing use. Healthcare providers and patients with this product should stop dispensing or using it and contact RemedyRepack Inc. or their pharmacy for instructions on returning the product or obtaining replacement medication from another source.

The recalled product

Product
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard
  • cgmp-deviation
  • quality-assurance-failure

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: a) B2110254-021423
  • exp. date 08/17/2023
  • b) J0684183-022323
  • exp. date 02/28/2024

Distribution

Distributed in 1 state:

  • PA

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