The Recall Desk
ModerateFDA (Drugs)·D-0012-2023·Announced 2022-10-26

Rifampin Capsules recalled due to excess nitrosamine impurity

Golden State Medical Supply Inc. is recalling Rifampin Capsules, 150 mg, due to elevated levels of 1-Methyl-4-Nitrosopiperazine (MNP) exceeding the FDA interim specification limit of 5 ppm. Affected lots are 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: This is an FDA Class II drug recall for a quality specification failure. No illnesses or injuries have been reported. The hazard is an elevated impurity level rather than an immediate safety threat, consistent with precautionary recalls.

Plain-English summary

Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 150 mg, 30-count bottles. The recall affects specific lots with expiration dates ranging from October 31, 2022, through February 29, 2024. The product was manufactured by Patheon Pharmaceuticals Inc. in Ohio and packaged by GSMS, Incorporated in California.

The recall was initiated because the finished product exceeds the FDA interim specification limit of 5 ppm for 1-Methyl-4-Nitrosopiperazine (MNP), a degradation impurity. This represents a failure to meet established quality standards.

The affected lots have been distributed throughout the United States. Patients currently taking Rifampin from these lots should contact their healthcare provider or pharmacist before making any changes to their medication regimen.

The recalled product

Product
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription / Antibiotic
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 (19)

  • Lot #: GS036715
  • GS037569
  • GS038132
  • GS038665
  • GS038750
  • GS039565
  • GS039997
  • GS040673
  • Exp 10/31/2022
  • GS040674
  • GS041237
  • GS041652
  • GS042152
  • GS043365
  • Exp 3/31/2023
  • GS045441
  • GS045677
  • GS046111
  • Exp 2/29/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Golden State Medical Supply 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 2 products in this recall →

Related recalls

Same manufacturer · Golden State Medical Supply Inc.

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Same hazard · nitrosamine impurity

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