FDA recall D-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.

Reason for recall

Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-01-21

Report date

2015-03-04

Termination date

2015-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sharm, N/A, United Arab Emirates

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0394-2015