The Recall Desk
HighFDA (Drugs)·D-0011-2023·Announced 2022-10-26

Rifampin Capsules recalled due to excessive impurity levels

Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, because samples exceeded acceptable limits for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Multiple lot numbers were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or adverse events. The hazard involves an impurity exceeding acceptable manufacturing limits, constituting a potential safety risk. Per the rubric, since no illnesses or injuries have been reported and the hazard is theoretical rather than demonstrated, the maximum score is 3 (High).

Plain-English summary

Golden State Medical Supply Inc. is recalling Rifampin Capsules, USP, 300 mg, due to failed quality specifications. The product is manufactured by Patheon Pharmaceuticals Inc. in Ohio and packaged by GSMS, Incorporated in California. The recall applies to specific lot numbers in three bottle sizes: 30-count (NDC 51407-323-30), 60-count (NDC 51407-323-60), and 100-count (NDC 51407-323-01).

Testing revealed that samples of the finished product exceeded the acceptable limit of 5 parts per million (ppm) for 1-Methyl-4-Nitrosopoperazine (MNP), an impurity. Lot numbers with expiration dates of January 31, 2023 and March 31, 2023 are affected, with different lot numbers impacted depending on the package size.

The recalled product was distributed nationwide. Healthcare providers and patients with affected lots should contact their pharmacist or Golden State Medical Supply Inc. for guidance regarding their medication.

The recalled product

Product
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug
Hazard
  • impurity

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 (20)

  • Lot#: a) GS041430
  • GS041941
  • Exp 1/31/2023
  • GS041315
  • GS042991
  • GS043027
  • GS043367
  • GS043501
  • GS044421
  • Exp 3/31/2023
  • b) GS041431
  • GS041799
  • GS042287
  • GS042414
  • GS042879
  • Exp: 1/31/2023
  • GS041316
  • GS042992
  • GS043368
  • GS043579

Distribution

Distributed nationwide across the United States.

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