Why it was recalled
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Product description
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
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0522-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 19, 2015
- FDA report date
- Dec 30, 2015
- Quantity
- 15,301 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Oasis Medical, Inc.
Original FDA data
Every field from FDA enforcement report D-0522-2016, exactly as published.
Show all FDA fields
- City
- Glendora
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 72517
- Address
- 514 S. Vermont Ave Bldg 510-528
- Code information
- 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.
- Postal code
- 91741-6205
- Report date
- Dec 30, 2015
- Product type
- Drugs
- Recall number
- D-0522-2016
- Classification
- Class III
- Recalling firm
- Oasis Medical, Inc.
- Product quantity
- 15,301 units
- Termination date
- Mar 14, 2016
- Reason for recall
- Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium
- Recall initiation date
- Oct 19, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 22, 2015