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.
Reported: March 4, 2015 Initiated: January 21, 2015 #D-0394-2015
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.
Reason for Recall
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Details
- Recalling Firm
- Sun Pharma Global Fze
- Units Affected
- 5322 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Sharm, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sun Pharma Global Fze. Units affected: 5322 bottles.
Why was this product recalled? ▼
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 4, 2015. Severity: Moderate. Recall number: D-0394-2015.
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