Bimatoprost Ophthalmic Solution recall: Impurity Out of Spec
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.)…
Why was Bimatoprost Ophthalmic Solution recalled?
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# H801686, Exp. 12/31/2019.
- 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.)…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 2,130 bottles
- Distribution
- Nationwide in the U.S.
- Recall date
- January 8, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)