Recalls / Class II
Class IID-0394-2015
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.
- Affected lot / code info
- Lot #: JKM5035A, Exp 07/15
Why it was recalled
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Recalling firm
- Firm
- Sun Pharma Global Fze
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Office # 43 Block Y Saif Zone, N/A, Sharm, N/A N/A, United Arab Emirates
Distribution
- Quantity
- 5322 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-01-21
- FDA classified
- 2015-02-20
- Posted by FDA
- 2015-03-04
- Terminated
- 2015-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0394-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.