Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Reported: August 24, 2022 Initiated: July 28, 2022 #D-1343-2022
Product Description
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Reason for Recall
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 7,872/30 count bottles
- Distribution
- Product was distributed nationwide.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 7,872/30 count bottles.
Why was this product recalled? ▼
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1343-2022.
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