D-0429-2019 Class III Terminated
FDA drug recall D-0429-2019 was initiated by Lupin Pharmaceuticals Inc. on January 28, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities. The recall status is terminated (terminated June 22, 2020). Affected quantity: 9,930 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 13, 2019
- Initiation Date
- January 28, 2019
- Termination Date
- June 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,930 bottles
Product Description
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
Reason for Recall
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Distribution Pattern
Nationwide within the United States.
Code Information
a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020