Multi event Drug Recall Enforcement Report Class III voluntary initiated by Lupin Pharmaceuticals Inc., originally initiated on 11-01-2019 for the product Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA The product was recalled due to presence of foreign substance: identified as a dead ant.. The product was distributed in Product Was Distributed To Major Distributors/wholesalers Throughout The United States. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0306-2020 | 11-01-2019 | 11-13-2019 | Class III | a) 4074 bottles b) 30,300 bottles | Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA | Presence of Foreign substance: identified as a dead ant. | Terminated |
| D-0304-2020 | 11-01-2019 | 11-13-2019 | Class III | 28,254 bottles | Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02 | Presence of Foreign substance: identified as a dead ant. | Terminated |
| D-0305-2020 | 11-01-2019 | 11-13-2019 | Class III | 30,516 bottles | Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10 | Presence of Foreign substance: identified as a dead ant. | Terminated |
Recalled Products
