FDAClass IIIDecember 30, 2015

HPMC Visoelastic Topical recall

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

Why was HPMC Visoelastic Topical recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
Oasis Medical, Inc.
Quantity
3,358 units
Distribution
Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
Recall date
December 30, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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