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Recall -- Firm Press Release

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Quality Care Products L.L.C. Able Laboratories Inc. Nationwide Recall

Contact:
Quality Care Products
800-337-8603

FOR IMMEDIATE RELEASE -- Temperence, MI -- June 15, 2005 -- Quality Care Products, LLC, Temperance, MI, a federally licensed drug re-packager with the FDA and DEA, is initiating a nationwide recall of any and all numbers they repackaged from drugs that were manufactured by Able Laboratories Inc., Cranbury, NJ. This recall is due to Able Laboratories voluntary recall of all of their drug products because of the FDA's serious concerns that they were not produced according to quality assurance standards.

The Agency recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product. Consumers should continue taking the medication until they have spoken with their health care provider. In many cases the risk of suddenly stopping needed medication before getting replacement drugs may outweigh the risk of continuing to use the recalled products.

The list below provides the names of the recalled drugs and their imprint codes. Imprints are marks (usually letters and numbers) found on the surface of a capsule and or tablet. If you have one of the drugs listed below with one of the corresponding imprint codes, your drug is covered by the Quality Care Products recall. Liquid products that are being recalled can be identified by the lot numbers printed on their packaging.

It is important to note that this recall only applies to the drugs produced by Able Laboratories -- and not to the same drugs produced by other manufacturers.

The recall includes the following:

Item #

Description and Strength

0001861

PHENAZOPYRIDINE HCI 100MG 8

0001862

PHENAZOPYRIDINE HCI 100MG 10

0001863

PHENAZOPYRIDINE HCI 100MG 12

0001864

PHENAZOPYRIDINE HCI 100MG 15

0066979

PHENAZOPYRIDINE HCI 200MG 6

0001874

PHENAZOPYRIDINE HCI 200MG 9

0001875

PHENAZOPYRIDINE HCI 200MG 10

0067315

PHENAZOPYRIDINE HCI 200MG 15

0001960

PROPOXACET N 100/650MG 15

0066494

PROPOXACET N 100/650MG 30

0001959

PROPOXACET N 100/650MG 12

0001963

PROPOXACET N 100/650MG 20

0001965

PROPOXACET N 100/650MG 30

0066596

PROPOXACET N 100/650MG 60

0067249

PROPOXACET N 100/650MG 6

0067187

PROPOXACET N 100/650MG 50

0066685

PROPOXACET N 100/650MG 12

0067105

PROPOXACET N 100/650MG 90

0066915

PROPOXACET N 100/650MG 100

0067114

NAPROXEN SOD. 275MG 60

0067212

NAPROXEN SOD. 550MG 20

0001939

NAPROXEN SOD. 550MG 28

0001940

NAPROXEN SOD. 550MG 30

0067092

NAPROXEN SOD. 550MG 60

0005851

METRONIDAZOLE 500MG 100

0001265

METRONIDAZOLE 500MG 28

0001264

METRONIDAZOLE 500MG 21

0001260

METRONIDAZOLE 500MG 14

0067313

METRONIDAZOLE 250MG 100

0001251

METRONIDAZOLE 250MG 28

0067203

INDOMETHACIN 75MG ER 30

0067186

INDOMETHACIN 50MG 50

0001797

INDOMETHACIN 50MG 30

0067398

INDOMETHACIN 50MG 21

0067339

INDOMETHACIN 50MG 15

0001789

INDOMETHACIN 25MG 20

0001792

INDOMETHACIN 25MG 90

0001790

INDOMETHACIN 25MG 30

0067338

INDOMETHACIN 25MG 15

0067451

ACETAMINOPHEN W/COD 300/60MG 120

0067450

ACETAMINOPHEN W/COD 300/60MG 90

0000493

ACETAMINOPHEN W/COD 300/60MG 30

0066493

ACETAMINOPHEN W/COD 300/60MG 2

0067304

ACETAMINOPHEN W/COD 300/30MG 1

0000363

ACETAMINOPHEN W/COD 300/30MG 10

0000364

ACETAMINOPHEN W/COD 300/30MG 12

0000365

ACETAMINOPHEN W/COD 300/30MG 15

0000368

ACETAMINOPHEN W/COD 300/30MG 20

0000371

ACETAMINOPHEN W/COD 300/30MG 30

0000373

ACETAMINOPHEN W/COD 300/30MG 50

0000374

ACETAMINOPHEN W/COD 300/30MG 60

The FDA has been apprised of this action. No injuries from this recall have been reported, to date. These products were distributed to Physician office dispensaries in over 12 States. A copy of a sample label is attached to help you to identify these products.

The company has already notified all of their Physician dispensaries via letter, and has arranged for a replacement of all full or partially filled bottles. Consumers with questions may contact the company via e-mail at consumer@qcpmeds.com or call 800-337-8603 between the hours of 8am to 5pm EST.




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