CLASS III Drug recall · Reported 30 Dec 2015 · FDA Enforcement Report
HPMC Visoelastic, 20,000 cps, Reference recalled by Oasis Medical
Oasis Medical is recalling HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private, 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-0522-2016
- 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 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, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 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
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 #: V0814H, V0814J, Exp 08/2016; V1014L, Exp 11/2016; V1114A, Exp 11/2016; V0115G, V0115H, Exp 01/2017; V0215A, V0215B, Exp 02/2017; V0315G, V0315H, V0315O, Exp 03/2017; V0515C, V0515D, Exp 05/2017.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 72517This product is part of a recall event; the main page for the event is Hpmc Visoelastic Topical, 8,000 cps, Reference recalled by Oasis Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Hpmc Visoelastic Topical, 8,000 cps, Reference recalled by Oasis Medical | Oasis Medical | Other | Nationwide | |
| CLASS III | Hpmc Visoelastic, 8,000 cps, Reference 51082, LT5108 recalled | Oasis Medical | Other | Nationwide |
More recalls from Oasis Medical
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile recalledOasis Tears Pf | Oasis Medical | Sterility | Nationwide |
| Drug | CLASS III | Hpmc Visoelastic, 8,000 cps, Reference 51082, LT5108 recalled | Oasis Medical | Other | Nationwide |
| Drug | CLASS III | Hpmc Visoelastic Topical, 8,000 cps, Reference recalled by Oasis Medical | Oasis Medical | Other | Nationwide |
| Drug | CLASS III | ImproVue Ophthalmic Lubricant Drops recalled by Oasis Medical | Oasis Medical | Other | FL |
| Drug | CLASS III | ImproVue Ophthalmic Lubricant Drops recalled by Oasis Medical | Oasis Medical | Other | FL |