Why it was recalled
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Product description
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.
Lot numbers, UPCs & expiration codes
a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
Where it was sold
Nationwide within the United States.
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-0429-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 28, 2019
- FDA report date
- Feb 13, 2019
- Quantity
- 9,930 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0429-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82022
- Address
- 111 S Calvert St Fl 21ST
- Code information
- a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
- Postal code
- 21202-6174
- Report date
- Feb 13, 2019
- Product type
- Drugs
- Recall number
- D-0429-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 9,930 bottles
- Termination date
- Jun 22, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States.
- Recall initiation date
- Jan 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2019