Drug product
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.
D-0429-2019
Product summary
- Event
- Event 82022
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,930 bottles
- Official record key
drug-enforcement:D-0429-2019
Official wording
Reason: Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Code information: a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
Distribution pattern: Nationwide within the United States.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications