D-1343-2022 Class II Terminated
FDA drug recall D-1343-2022 was initiated by Lupin Pharmaceuticals Inc. on Jul 28, 2022 and is designated Class II. Reason for recall: CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. The recall status is terminated (terminated Oct 5, 2023). Affected quantity: 7,872/30 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 24, 2022
- Initiation Date
- Jul 28, 2022
- Termination Date
- Oct 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,872/30 count bottles
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.
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot #A200170, exp. date December 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1343-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026