The Recall Desk
Agency classClass IIOur severity: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.

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: 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 →

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