Class II
Terminated
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
This recall has been terminated (originally issued November 27, 2024).
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- October 23, 2024
- Posted
- November 27, 2024
- Recall Number
- D-0053-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 146,322 bottles
- Firm Location
- Baltimore, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Distribution
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Lot / Code Info
a) NDC 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25
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