D-0635-2020 Class III Terminated
FDA drug recall D-0635-2020 was initiated by Lupin Pharmaceuticals Inc. on December 13, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity. The recall status is terminated (terminated October 19, 2020). Affected quantity: 2,130 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2020
- Initiation Date
- December 13, 2019
- Termination Date
- October 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,130 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot# H801686, Exp. 12/31/2019.