Accusure (Qualitest) Insulin Syringe Recall

[We Hope]

http://www.fda.gov/Safety/Recalls/ucm179943.htm

Qualitest Pharmaceuticals, Inc.Issues a Voluntary Nationwide Recall of
Accusure® Insulin Syringes (1/2 Cc – 31 G – Short Needle) Lot #6jcb1 and Accusure® Insulin Syringes (1 Cc – 31 G – Short Needle) Lot #7cpt1

FOR IMMEDIATE RELEASE -- August 21, 2009 -- Huntsville, AL - Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-21. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies nationwide (including Puerto Rico). Also today, Qualitest has issued a voluntary nationwide recall of Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21 This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots have been found to have needles which can detach from the syringe.

When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection.

Consumers who have any Accusure® Insulin Syringes (1/2 cc – 31 G –Short Needle) with lot number 6JCB1 or Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received the product and arranging for return of any affected product.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

This is for:

Accusure® Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-21

Accusure® Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21

[We Hope]

Re: Accusure (Qualitest) Insulin Syringe Recall

http://www.fda.gov/Safety/Recalls/En.../ucm170185.htm

US-FDA Enforcement Report July 1, 2009

PRODUCT

AccuSure, U-100 31 Gauge, Icc Insulin Syringe, 5/16” (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2. Recall # Z-1504-2009

CODE

Lot A07001, exp 07/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL, by press release and letter on April 9, 2009.

Manufacturer: Feel Tech, Chungnam, Republic of South Korea. Firm initiated recall is ongoing.

REASON

Needles separate from the barrel of the syringe.

VOLUME OF PRODUCT IN COMMERCE

559,500 syringes

DISTRIBUTION

Nationwide

Note that this is the second recent recall for one of these products.

[We Hope]

Re: Accusure (Qualitest) Insulin Syringe Recall

This rolling recall has been extended to cover ALL insulin syringes by Qualitest:

http://www.fda.gov/Safety/Recalls/ucm188137.htm

Qualitest Pharmaceuticals Issues a Voluntary Nationwide Recall of All Accusure® Insulin Syringes

FOR IMMEDIATE RELEASE - October 27, 2009 - Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers:

28G 1/2cc, NDC 0603-6995-21;
28G 1cc, NDC 0603-6996-21;
29G 1/2cc NDC 0603-6997-21,
29G 1cc, NDC 0603-6998-21,
30G 1/2cc, NDC 0603-999-21,
30G 1cc, NDC 0603-7000-21,
31G 1/2cc, NDC 0603-7001-21;
31G 1cc, NDC 0603-7002-21.

All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.