Rifampin Capsules recall: Impurity Out of Spec
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC…
Why was Rifampin Capsules recalled?
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC…
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- N/A
- Distribution
- USA nationwide
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)