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HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OAS...

FDA Recall #D-0524-2016 — Class III — October 19, 2015

Recall #D-0524-2016 Date: October 19, 2015 Classification: Class III Status: Terminated

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.

Recalling Firm

Oasis Medical, Inc. — Glendora, CA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

14,852 units

Distribution

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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