Why it was recalled
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: JKM5035A, Exp 07/15
Where it was sold
Nationwide and Puerto Rico
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-0394-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 21, 2015
- FDA report date
- Mar 4, 2015
- Quantity
- 5322 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharma Global Fze
Original FDA data
Every field from FDA enforcement report D-0394-2015, exactly as published.
Show all FDA fields
- City
- Sharm
- Status
- Terminated
- Country
- United Arab Emirates
- Event ID
- 70382
- Address
- Office # 43 Block Y Saif Zone
- Code information
- Lot #: JKM5035A, Exp 07/15
- Report date
- Mar 4, 2015
- Product type
- Drugs
- Recall number
- D-0394-2015
- Classification
- Class II
- Recalling firm
- Sun Pharma Global Fze
- Product quantity
- 5322 bottles
- Termination date
- Oct 23, 2015
- Reason for recall
- Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 21, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 20, 2015