Home / Recalls / Sun Pharma Global Fze / D-0394-2015

D-0394-2015 Class II Terminated

Recalled by Sun Pharma Global Fze — Sharm, N/A

Recall Details

Product Type
Drugs
Report Date
March 4, 2015
Initiation Date
January 21, 2015
Termination Date
October 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5322 bottles

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: JKM5035A, Exp 07/15

Other recalls by Sun Pharma Global Fze

  • D-0735-2016 Class II — Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, M (February 11, 2016)
  • D-1345-2015 Class III — buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day (July 17, 2015)
  • D-0386-2015 Class II — Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manuf (January 21, 2015)