RAMIPRIL
Wed Nov 27 2024
1 of 10
Summary
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India | Lupin Pharmaceuticals, Inc. | Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. | 357,414 bottles |
| Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India | Lupin Pharmaceuticals, Inc. | Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. | 112,770 bottles |
| 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 | Lupin Pharmaceuticals, Inc. | Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. | 146,322 bottles |