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
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
- Drug class
- Creams, Ointments & Gels
Timeline
| 19 Oct 2015 | Recall initiated by company | |
| 22 Dec 2015 | Classified by FDA | +64 days |
| 30 Dec 2015 | Published 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
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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|---|---|---|---|---|---|
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