D-0524-2016 Class III Terminated
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
- 14,852 units
Product Description
HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 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 #: V0814C, V0814D, Exp 8/2016; V1014A, V1014B, Exp 10/2016; V1214C, Exp 12/2016; V0115A, V0115B, Exp 01/2017; V0215C, Exp 02/2017; V0315C, V0315D, Exp 03/2017; V0515A, V0515B, Exp 05/2017.