Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: JKM5035A, Exp 07/15
- 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:
- Sun Pharma Global Fze
- Reason for Recall:
- Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.
Product Codes/Lot Numbers:
Lot #: JKM5035A, Exp 07/15
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0394-2015
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Failed Dissolution Specifications: 6 month time point.