Z-0567-05

Sterile Empty Vials for Allergenic Extracts, 100ml size

Name: Z-0567-05 Sterile Empty Vials for Allergenic Extracts, 100ml size
Creator: Greer Laboratories Inc
Published: 2005-01-28
License: https://open.fda.gov/license/

Greer Laboratories Inc / initiated 2005-01-28 / Terminated / root cause: sterility

FDA source

Greer Laboratories Inc began a recall of Sterile Empty Vials for Allergenic Extracts, 100ml size on 2005-01-28. The reason FDA records is "Product 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-0567-05
Status: Terminated
Initiated: 2005-01-28
Posted: 2005-03-01
Terminated: 2005-04-13
Recalling firm: Greer Laboratories Inc
Product: Sterile Empty Vials for Allergenic Extracts, 100ml size
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Product may not be sterile.
Root cause tag: sterility
FDA root cause: Other
Action: Consignees were first contacted by telephone, followed up with a letter on 01/28/2005.
Quantity in commerce: 2157 vials
Distribution: AZ, CA, FL, IL,KY, MA,MD, MI, NC, NJ, NM, OH, PA TN, TX, WI, WV, and Ontario Canada.
Product codes and lots: Item #SE08160, Lot 9406

Product code JKA

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)