Drug product
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
D-0635-2020
Product summary
- Event
- Event 84495
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,130 bottles
- Official record key
drug-enforcement:D-0635-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Code information: Lot# H801686, Exp. 12/31/2019.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Out-of-specification