Drug product
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.
D-0394-2015
Product summary
- Event
- Event 70382
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5322 bottles
- Official record key
drug-enforcement:D-0394-2015
Official wording
Reason: Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Code information: Lot #: JKM5035A, Exp 07/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter