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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Lupin Pharmaceuticals Inc.
- Reason for Recall:
- Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0429-2019
Related Recalls
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lupin Pharmaceuticals
Defective container - seal not adhering to bottles
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027