Z-1227-2010

CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz...

Name: Z-1227-2010 CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz...
Creator: K C Pharmaceuticals Inc
Published: 2010-02-03
License: https://open.fda.gov/license/

K C Pharmaceuticals Inc / initiated 2010-02-03 / Terminated / root cause: sterility

FDA source

K C Pharmaceuticals Inc began a recall of CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft... on 2010-02-03. The reason FDA records is "The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1227-2010
Status: Terminated
Initiated: 2010-02-03
Posted: 2010-04-02
Terminated: 2011-01-05
Recalling firm: K C Pharmaceuticals Inc
Product: CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
Product code: LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Reason for recall: The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Root cause tag: sterility
FDA root cause: Other
Action: An "Urgent: Medical Device Recall Notification" letter dated February 17, 2010 was issued to customers. Consignees were instructed to immediately hold and discontinue selling the existing, affected stock. Consignees were also instructed to check inventories at all distribution locations for affected products shipped between June 8, 2OO9 and August 7, 2009 and perform a SUBRECALL to the retail level and report back to KC Pharmaceuticals. If the retailers indicate they have any of the affected lots of product, please have them contact KC Pharmaceuticals at 1-888-527-4276 for a shipping authorization number. Consignees were asked to complete the enclosed Recall Effectiveness Check Form, even if they did not have the products in question and return the form to KC Pharmaceuticals via mail within five (5) business days. The recalled lot and completed packing slips were asked to be shipped to: KC Pharmaceuticals-SALP Recall, 3201 Producer Way, Pomona, CA 91768. Direct questions to KC Pharmaceuticals by calling 1-888-527-4276, extension 27.
Quantity in commerce: 10,500 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers: 9C523 and 9D524.

Product code LYL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)