Home / Recalls / Oasis Medical, Inc. / D-0523-2016

D-0523-2016 Class III Terminated

Recalled by Oasis Medical, Inc. — Glendora, CA

Recall Details

Product Type
Drugs
Report Date
December 30, 2015
Initiation Date
October 19, 2015
Termination Date
March 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,358 units

Product Description

HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741

Reason for Recall

Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Distribution Pattern

Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium

Code Information

Lot #: V1014M, Exp 10/2016; V1214B, Exp 12/2016; V0415H, Exp 4/2017.

Other recalls by Oasis Medical, Inc.

  • D-0522-2016 Class III — HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (P (October 19, 2015)
  • D-0524-2016 Class III — HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in (October 19, 2015)
  • D-1418-2015 Class III — ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0 (August 31, 2015)
  • D-1084-2015 Class III — ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0 (April 10, 2015)
  • D-1347-2014 Class III — Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed (May 14, 2014)