• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

 
0001861PHENAZOPYRIDINE HCI 100MG 8
0001862PHENAZOPYRIDINE HCI 100MG 10
0001863PHENAZOPYRIDINE HCI 100MG 12
0001864PHENAZOPYRIDINE HCI 100MG 15
0066979PHENAZOPYRIDINE HCI 200MG 6
0001874PHENAZOPYRIDINE HCI 200MG 9
0001875PHENAZOPYRIDINE HCI 200MG 10
0067315PHENAZOPYRIDINE HCI 200MG 15
0001960PROPOXACET N 100/650MG 15
0066494PROPOXACET N 100/650MG 30
0001959PROPOXACET N 100/650MG 12
0001963PROPOXACET N 100/650MG 20
0001965PROPOXACET N 100/650MG 30
0066596PROPOXACET N 100/650MG 60
0067249PROPOXACET N 100/650MG 6
0067187PROPOXACET N 100/650MG 50
0066685PROPOXACET N 100/650MG 12
0067105PROPOXACET N 100/650MG 90
0066915PROPOXACET N 100/650MG 100
0067114NAPROXEN SOD. 275MG 60
0067212NAPROXEN SOD. 550MG 20
0001939NAPROXEN SOD. 550MG 28
0001940NAPROXEN SOD. 550MG 30
0067092NAPROXEN SOD. 550MG 60
0005851METRONIDAZOLE 500MG 100
0001265METRONIDAZOLE 500MG 28
0001264METRONIDAZOLE 500MG 21
0001260METRONIDAZOLE 500MG 14
0067313METRONIDAZOLE 250MG 100
0001251METRONIDAZOLE 250MG 28
0067203INDOMETHACIN 75MG ER 30
0067186INDOMETHACIN 50MG 50
0001797INDOMETHACIN 50MG 30
0067398INDOMETHACIN 50MG 21
0067339INDOMETHACIN 50MG 15
0001789INDOMETHACIN 25MG 20
0001792INDOMETHACIN 25MG 90
0001790INDOMETHACIN 25MG 30
0067338INDOMETHACIN 25MG 15
0067451ACETAMINOPHEN W/COD 300/60MG 120
0067450ACETAMINOPHEN W/COD 300/60MG 90
0000493ACETAMINOPHEN W/COD 300/60MG 30
0066493ACETAMINOPHEN W/COD 300/60MG 2
0067304ACETAMINOPHEN W/COD 300/30MG 1
0000363ACETAMINOPHEN W/COD 300/30MG 10
0000364ACETAMINOPHEN W/COD 300/30MG 12
0000365ACETAMINOPHEN W/COD 300/30MG 15
0000368ACETAMINOPHEN W/COD 300/30MG 20
0000371ACETAMINOPHEN W/COD 300/30MG 30
0000373ACETAMINOPHEN W/COD 300/30MG 50
0000374ACETAMINOPHEN 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.

####

 

RSS Feed for FDA Recalls Information [what's this?]