Why it was recalled
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Product description
GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
Lot numbers, UPCs & expiration codes
Lot #: 86041601, Exp 09/19
Where it was sold
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
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-0551-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 9, 2017
- FDA report date
- Mar 7, 2018
- Quantity
- 60,000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kareway Products Inc
Original FDA data
Every field from FDA enforcement report D-0551-2018, exactly as published.
Show all FDA fields
- City
- Compton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78541
- Address
- 2550 S Dominguez Hills Dr
- Code information
- Lot #: 86041601, Exp 09/19
- Postal code
- 90220-6401
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0551-2018
- Classification
- Class I
- Recalling firm
- Kareway Products Inc
- Product quantity
- 60,000 bottles
- Termination date
- Aug 7, 2019
- Reason for recall
- Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
- Distribution pattern
- Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
- Recall initiation date
- Nov 9, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2018