Drug product
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
D-0524-2016
Product summary
- Event
- Event 72517
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,852 units
- Official record key
drug-enforcement:D-0524-2016
Official wording
Reason: Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
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.
Distribution pattern: Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Derived failure modes
-
Potency or specification failure
may not meet specification