Z-0871-06

Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier...

Name: Z-0871-06 Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier...
Creator: Hollister Stier Laboratories LLC
Published: 2006-04-20
License: https://open.fda.gov/license/

Jubilant Hollisterstier LLC / initiated 2006-04-20 / Terminated / root cause: sterility

FDA source

Hollister Stier Laboratories LLC began a recall of Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on... on 2006-04-20. The reason FDA records is "Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials". 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-0871-06
Status: Terminated
Initiated: 2006-04-20
Posted: 2006-05-17
Terminated: 2007-03-03
Recalling firm: Jubilant Hollisterstier LLC
Product: Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207
Product code: LDH
Reason for recall: Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.
Root cause tag: sterility
FDA root cause: Other
Action: On 4/20/06 the firm sent an overnight letter titled DEVICE RECALL to their customers. The consignees were advised of the problem and were requested return of the vials. The letter also instructs consignees that if they have any remaining product in the vials, to destroy the product.
Quantity in commerce: 87,900 vials
Distribution: Vials were distributed to clinics, pharmacies and physicians nationwide.
Product codes and lots: Lot #6743 Item #s 7515ZA, 7515ZC, 7515ZD

Product code LDH

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)