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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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FDA Press Release (May 27, 2005)
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