FDA Drug recall D-0522-2016
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL S…
- FDA Drug
- Class III
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class III recall of HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL S… by Oasis Medical, citing failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0522-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-19 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Oasis Medical |
| Distribution | US |
Product
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
Reason
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Identifiers
| code_info | Lot #: V0814H, V0814J, Exp 08/2016; V1014L, Exp 11/2016; V1114A, Exp 11/2016; V0115G, V0115H, Exp 01/2017; V0215A, V0…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0522-2016%22
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