Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Reported: December 28, 2022 Initiated: December 7, 2022 #D-0089-2023
Product Description
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Reason for Recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 23,736
- Distribution
- Product was distributed by major distribution chains nationwide.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 23,736.
Why was this product recalled? ▼
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2022. Severity: Moderate. Recall number: D-0089-2023.
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