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FDA advises consumers about recalled drugs from Able Laboratories.

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M2 PRESSWIRE-6 June 2005-US FDA: FDA advises consumers about recalled drugs from Able Laboratories(C)1994-2005 M2 COMMUNICATIONS LTD

RDATE:03062005

The Food and Drug Administration (FDA) is taking action to ensure that the public is fully aware that Able Laboratories of Cranbury, NJ, is conducting a nationwide recall of all of its manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production.

"The FDA continues to evaluate the situation at Able Laboratories to determine the safety and quality of their products and will update the public on our findings as necessary," said Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs. "In the meantime, 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 surfaces of drugs. If you have one of the drugs listed below with one of the corresponding imprint codes, your drug is covered by the Able Laboratories 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.

Recalled Able Drugs:

GENERIC NAME

SIZE

Imprint Side 1

Imprint side 2

ACETAMINOPHEN & CODEINE 300MG -30MG TAB

100

A285

3

ACETAMINOPHEN & CODEINE 300MG -30MG TAB

500

A285

3

ACETAMINOPHEN & CODEINE 300MG -30MG TAB

1000

A285

3

ACETAMINOPHEN & CODEINE 300MG -60MG TAB

100

A286

4

ACETAMINOPHEN & CODEINE 300MG -60MG TAB

500

A286

4

ACETAMINOPHEN & CODEINE 300MG -60MG TAB

1000

A286

4

ATENOLOL TABLETS 25 MG TAB

100

A412

ATENOLOL TABLETS 25 MG TAB

1000

A412

ATENOLOL TABLETS 50 MG TAB

100

A413

ATENOLOL TABLETS 50 MG TAB

1000

A413

ATENOLOL TABLETS 100 MG TAB

100

A414

ATENOLOL TABLETS 100 MG TAB

1000

A414

BETHANECHOL CHLORIDE TABS 5 MG TAB

100

A339

BETHANECHOL CHLORIDE TABS 10 MG TAB

100

A340

BETHANECHOL CHLORIDE TABS 25 MG TAB

100

A338

BETHANECHOL CHLORIDE TABS 50 MG TAB

100

A341

BUTALBITAL/APAP/CAFFEINE 50-325-40 MG TAB

100

A236

BUTALBITAL/APAP/CAFFEINE 50-325-40 MG TAB

500

A236

BUTALBITAL/APAP/CAFFEINE 50-500-40 MG TAB

100

A235

BUTALBITAL/APAP/CAFFEINE 50-500-40 MG TAB

500

A235

BUTALBITAL/APAP/CAFF/CODEINE 50/325/40/30 CAP

100

A

240

CARISOPRODOL 350 MG TAB

100

A266

CARISOPRODOL 350 MG TAB

500

A266

CARISOPRODOL 350 MG TAB

1000

A266

CLORAZEPATE DIPOTASSIUM 3.75 MG TAB

100

AL

CLORAZEPATE DIPOTASSIUM 3.75 MG TAB

500

AL

CLORAZEPATE DIPOTASSIUM 7.5 MG TAB

100

AM

CLORAZEPATE DIPOTASSIUM 7.5 MG TAB

500

AM

CLORAZEPATE DIPOTASSIUM 15 MG TAB

100

AN

DIPHENOXYLATE/ATROPINE 2.5-0.025 MG TAB

100

A

237

DIPHENOXYLATE/ATROPINE 2.5-0.025 MG TAB

1000

A

237

HYDROCODONE BITARTRATE APAP 5-325 MG TAB

100

A345

HYDROCODONE BITARTRATE APAP 5-325 MG TAB

500

A345

HYDROCODONE BITARTRATE APAP 5-500 MG TAB

100

A329

HYDROCODONE BITARTRATE...