Z-0574-2010

AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per...

Name: Z-0574-2010 AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per...
Creator: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Published: 2009-10-27
License: https://open.fda.gov/license/

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals / initiated 2009-10-27 / Terminated

FDA source

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals began a recall of AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21 on 2009-10-27. The reason FDA records is "Needles are becoming dislodged from the barrels". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0574-2010
Status: Terminated
Initiated: 2009-10-27
Posted: 2009-12-28
Terminated: 2010-11-24
Recalling firm: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Product: AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21
Product code: FMF Syringe, Piston
Reason for recall: Needles are becoming dislodged from the barrels.
FDA root cause: Other
Action: The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.
Quantity in commerce: 171,421 cartons of 100
Distribution: Nationwide
Product codes and lots: all lots

Product code FMF

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)