Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
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.
Lot numbers, UPCs & expiration codes
Lot# H801686, Exp. 12/31/2019.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0635-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 13, 2019
- FDA report date
- Jan 8, 2020
- Quantity
- 2,130 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0635-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 84495
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot# H801686, Exp. 12/31/2019.
- Postal code
- 21202-6174
- Report date
- Jan 8, 2020
- Product type
- Drugs
- Recall number
- D-0635-2020
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 2,130 bottles
- Termination date
- Oct 19, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Dec 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2020