CLASS III Drug recall · Reported 30 Dec 2015 · FDA Enforcement Report

Hpmc Visoelastic Topical, 8,000 cps, Reference recalled by Oasis Medical

Oasis Medical is recalling Hpmc Visoelastic Topical, 8,000 cps, Reference 5200 in Syringe, Oasis Medical Inc, 514, distributed nationwide in the US. The recall was initiated on 19 Oct 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: V1014M, Exp 10/2016; V1214B, Exp 12/2016; V0415H, Exp 4/2017.
Quantity recalled3,358 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0523-2016
FDA event ID
72517
Recalling firm
Oasis Medical, Glendora, CA
Classification
Class III
Status
Terminated
Recall initiated
19 Oct 2015
FDA classified
22 Dec 2015
Reported
30 Dec 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

19 Oct 2015Recall initiated by company
22 Dec 2015Classified by FDA+64 days
30 Dec 2015Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is Hpmc Visoelastic Topical, 8,000 cps, Reference 5200 in Syringe, Oasis Medical Inc, 514 recalled?

Yes. Oasis Medical recalled Hpmc Visoelastic Topical, 8,000 cps, Reference 5200 in Syringe, Oasis Medical Inc, 514 on 19 Oct 2015. The recall is Class III and its status is Terminated. Recall number D-0523-2016.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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