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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-26
May 27, 2005

Media Inquiries: Brad Stone, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Advises Consumers about Recalled Drugs from Able Laboratories

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 NAMESIZEImprint Side 1Imprint side 2
ACETAMINOPHEN & CODEINE 300MG -30MG TAB100A2853
ACETAMINOPHEN & CODEINE 300MG -30MG TAB500A2853
ACETAMINOPHEN & CODEINE 300MG -30MG TAB1000A2853
ACETAMINOPHEN & CODEINE 300MG -60MG TAB100A2864
ACETAMINOPHEN & CODEINE 300MG -60MG TAB500A2864
ACETAMINOPHEN & CODEINE 300MG -60MG TAB1000A2864
ATENOLOL TABLETS 25 MG TAB100A412 
ATENOLOL TABLETS 25 MG TAB1000A412 
ATENOLOL TABLETS 50 MG TAB100A413 
ATENOLOL TABLETS 50 MG TAB1000A413 
ATENOLOL TABLETS 100 MG TAB100A414 
ATENOLOL TABLETS 100 MG TAB1000A414 
BETHANECHOL CHLORIDE TABS 5 MG TAB100A339 
BETHANECHOL CHLORIDE TABS 10 MG TAB100A340 
BETHANECHOL CHLORIDE TABS 25 MG TAB100A338 
BETHANECHOL CHLORIDE TABS 50 MG TAB100A341 
BUTALBITAL/APAP/CAFFEINE 50-325-40 MG TAB100A236 
BUTALBITAL/APAP/CAFFEINE 50-325-40 MG TAB500A236 
BUTALBITAL/APAP/CAFFEINE 50-500-40 MG TAB100A235 
BUTALBITAL/APAP/CAFFEINE 50-500-40 MG TAB500A235 
BUTALBITAL/APAP/CAFF/CODEINE 50/325/40/30 CAP100A240
CARISOPRODOL 350 MG TAB100A266 
CARISOPRODOL 350 MG TAB500A266 
CARISOPRODOL 350 MG TAB1000A266 
CLORAZEPATE DIPOTASSIUM 3.75 MG TAB100AL 
CLORAZEPATE DIPOTASSIUM 3.75 MG TAB500AL 
CLORAZEPATE DIPOTASSIUM 7.5 MG TAB100AM 
CLORAZEPATE DIPOTASSIUM 7.5 MG TAB500AM 
CLORAZEPATE DIPOTASSIUM 15 MG TAB100AN 
DIPHENOXYLATE/ATROPINE 2.5-0.025 MG TAB100A237
DIPHENOXYLATE/ATROPINE 2.5-0.025 MG TAB1000A237
HYDROCODONE BITARTRATE APAP 5-325 MG TAB100A345 
HYDROCODONE BITARTRATE APAP 5-325 MG TAB500A345 
HYDROCODONE BITARTRATE APAP 5-500 MG TAB100A329 
HYDROCODONE BITARTRATE APAP 5-500 MG TAB500A329 
HYDROCODONE BITARTRATE APAP 7.5-325 MG TAB100A335 
HYDROCODONE BITARTRATE APAP 7.5-325 MG TAB500A335 
HYDROCODONE BITARTRATE APAP 7.5-500 MG TAB100A330 
HYDROCODONE BITARTRATE APAP 7.5-500 MG TAB500A330 
HYDROCODONE BITARTRATE APAP 7.5-650 MG TAB100A332 
HYDROCODONE BITARTRATE APAP 7.5-650 MG TAB500A332 
HYDROCODONE BITARTRATE APAP 7.5-750 MG TAB100A334 
HYDROCODONE BITARTRATE APAP 7.5-750 MG TAB500A334 
HYDROCODONE BITARTRATE APAP 10-325 MG TAB100A328 
HYDROCODONE BITARTRATE APAP 10-325 MG TAB500A328 
HYDROCODONE BITARTRATE APAP 10-500 MG TAB100A331 
HYDROCODONE BITARTRATE APAP 10-500 MG TAB500A331 
HYDROCODONE BITARTRATE APAP 10-650 MG TAB100A333 
HYDROCODONE BITARTRATE APAP 10-650 MG TAB500A333 
HYDROCORTISONE ACETATE 25 MG SUPP12AL0761F/02(foil) 
HYDROCORTISONE ACETATE 25 MG SUPP24AL0761F/02(foil) 
HYDROXYZINE HCL 10 MG TAB100A387
HYDROXYZINE HCL 10 MG TAB500A387
HYDROXYZINE HCL 10 MG TAB1000A387
HYDROXYZINE HCL 25 MG TAB100A388
HYDROXYZINE HCL 25MG TAB500A388
HYDROXYZINE HCL 25 MG TAB1000A388
HYDROXYZINE HCL 50 MG TAB100A389
HYDROXYZINE HCL 50 MG TAB500A389
HYDROXYZINE HCL 50 MG TAB1000A389
INDOMETHACIN 25 MG CAP100267A
INDOMETHACIN 25 MG CAP1000267A
INDOMETHACIN 50 MG CAP100268A
INDOMETHACIN 50 MG CAP500268A
INDOMETHACIN ER 75 MG CAP60A269
INDOMETHACIN ER 75 MG CAP100A269
LITHIUM CARBONATE 150 MG CAP100A355
LITHIUM CARBONATE 150 MG CAP500A355
LITHIUM CARBONATE 300 MG CAP100A270
LITHIUM CARBONATE 300 MG CAP1000A270
LITHIUM CARBONATE ER 300 MG TAB100A283 
LITHIUM CARBONATE 600 MG CAP100A356
METHAMPHETAMINE 5 MG TAB CII100A396 
METHOCARBAMOL 500 MG TAB100A265 
METHOCARBAMOL 500 MG TAB500A265 
METHOCARBAMOL 750 MG TAB100A264 
METHOCARBAMOL 750 MG TAB500A264 
METHYLPHENIDATE HCl 5 MG TAB CII100A253
METHYLPHENIDATE HCl 5 MG TAB CII1000A253
METHYLPHENIDATE HCl 10 MG TAB CII100A254
METHYLPHENIDATE HCl 10 MG TAB CII1000A254
METHYLPHENIDATE HCl 20 MG TAB CII100A255
METHYLPHENIDATE HCl 20 MG TAB CII1000A255
METHYLPHENIDATE HCl ER 20 MG TAB CII100A262 
METHYLPHENIDATE HCl ER 20 MG TAB CII1000A262 
METRONIDAZOLE 250 MG TAB100A374 
METRONIDAZOLE 250 MG TAB250A374 
METRONIDAZOLE 250 MG TAB500A374 
METRONIDAZOLE 500 MG TAB60A375 
METRONIDAZOLE 500 MG TAB100A375 
METRONIDAZOLE 500 MG TAB500A375 
METRONIDAZOLE ER 750 MG TAB30A352 
METRONIDAZOLE 375 MG CAP50A353
NAPROXEN SODIUM 275 MG TAB100A363 
NAPROXEN SODIUM 275 MG TAB500A363 
NAPROXEN SODIUM 550 MG TAB100A364 
NAPROXEN SODIUM 550 MG TAB500A364 
NITROGLYCERIN SUBLINGUAL 0.3 MG SL TAB1001 
NITROGLYCERIN SUBLINGUAL 0.4 MG SL TAB1002 
NITROGLYCERIN SUBLINGUAL 0.4 MG SL TAB4X252 
NITROGLYCERIN SUBLINGUAL 0.6 MG SL TAB1003 
PHENAZOPYRIDINE HCl 100 MG TAB100AP1 
PHENAZOPYRIDINE HCl 100 MG TAB1000AP1 
PHENAZOPYRIDINE HCl 200 MG TAB100AP2 
PHENAZOPYRIDINE HCl 200 MG TAB1000AP2 
PHENTERMINE POWDER 15 MG CAP100A346
PHENTERMINE POWDER 15 MG CAP1000A346
PHENTERMINE BEADS 30 MG CAP100A259
PHENTERMINE BEADS 30 MG CAP1000A259
PHENTERMINE POWDER 30 MG CAP100A258
PHENTERMINE POWDER 30 MG CAP1000A258
PHENTERMINE 37.5 MG TAB100A257 
PHENTERMINE 37.5 MG TAB1000A257 
PROCHLORPERAZINE 2.5 MG SUPP12AL0762F 
PROCHLORPERAZINE 5 MG SUPP12AL0763F 
PROCHLORPERAZINE 25 MG SUPP12AL0746F 
PROMETHAZINE 12.5MG SUPP12AL0765/01 
PROMETHAZINE 25 MG SUPP12AL0766F/01 
PROMETHAZINE 50 MG SUPP12AL0767F/01 
PROMETHAZINE TABLETS 12.5 MG TAB100A405 
PROMETHAZINE TABLETS 25 MG TAB100A406 
PROMETHAZINE TABLETS 25 MG TAB1000A406 
PROMETHAZINE TABLETS 50 MG TAB100A407 
PROPOXYPHENE NAPS/APAP 100-650 MG TAB100A256 
PROPOXYPHENE NAPS/APAP 100-650 MG TAB500A256 
PROPOXYPHENE NAPS/APAP 100-650 MG TAB1000A256 
PROPOXYPHENE NAPS/APAP 100-650 MG TAB100A261 
PROPOXYPHENE NAPS/APAP 100-650 MG TAB500A261 
PROPOXYPHENE NAPS/APAP 100-650 MG TAB1000A261 
SALSALATE 500 MG TAB100A500 
SALSALATE 500 MG TAB500A500 
SALSALATE 750 MG TAB100A750 
SALSALATE 750 MG TAB500A750 
THEOPHYLLINE ER 400 MG TAB100A380 
THEOPHYLLINE ER 400 MG TAB500A380 
THEOPHYLLINE ER 600 MG TAB100A382 
    
Ivax Label -Private Label Manufactured by Able LabsImprintLot #Lot #
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306060A402154A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306061A402155A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306062A402156A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306063A402157A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306063A402158A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306064A402158A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306065A402159A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306066A402166A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306067A402167A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306068A402168A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306068A402169A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306069A402170A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306070A403001A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306071A403002A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306072A403003A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306073A403004A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980306074A403005A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307011A403006A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307012A403007A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307013A403008A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307014A403009A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307015A403010A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307016A403099A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307017A403100A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307018A403101A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307019A403102A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307019A403103A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307020A403104A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307126A403105A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307127A403106A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307128A403107A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307129A403107A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307130A403108A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307131A403108A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307132A403157A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307133A403157A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307134A403157A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307135A403158A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307296A403158A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307297A403159A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307298A403160A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980307299A403161A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309013A403164A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309014A403165A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309015A403166A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309016A403167A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309017A403168A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309018A404046A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980309019A404047A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980310113A404047A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980310114A404048A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980310115A404049A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980310116A404050A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980310117A404087A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312011A404088A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312011A404089A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312012A404090A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312013A404091A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312013A404105A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312014A404106A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312014A404107A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312015A404108B
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312015A404108B
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312021A404109A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312022A404109A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312023A406116A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312024A406116A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312024A406117A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312025A406117A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312141A406118A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312142A406118A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312143A406119A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312144A406119A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312144A406120A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980312145A406121A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980401077A406122A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980401078A406123A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980401079A406124A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980401080A406125A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980401081A410059A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402047A410060A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402048A410061A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402049A410062A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402050A410063A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402051A410064A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402069A410065A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402069A410065A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402070A410066A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402071A410067A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402072A410068A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402073A411030A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402150A411031A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402151A411032A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402152A411033A
PROPOXYPHENE NAPS/APAP 100-650 MG TABZ4980402153A411034A
Tramadol HCL Tabs 50mg 10x10's (blister) Ivax 402165A 
Tramadol HCL Tabs 50mg 10x10's (blister) Ivax 410132A 
Tramadol HCL Tabs 50mg 10x10's (blister) Ivax 411118B 
TRAMADOL HCL 50MG TABSA273401174A405046A
TRAMADOL HCL 50MG TABSA273401175A405047A
TRAMADOL HCL 50MG TABSA273401176A405048A
TRAMADOL HCL 50MG TABSA273401177A405049A
TRAMADOL HCL 50MG TABSA273401178A405050A
TRAMADOL HCL 50MG TABSA273402161A405075A
TRAMADOL HCL 50MG TABSA273402162A405076A
TRAMADOL HCL 50MG TABSA273402163A405077A
TRAMADOL HCL 50MG TABSA273402164A405078A
TRAMADOL HCL 50MG TABSA273405070A410182A
TRAMADOL HCL 50MG TABSA273405071A411115A
TRAMADOL HCL 50MG TABSA273405072A411116A
TRAMADOL HCL 50MG TABSA273405073A411117A
TRAMADOL HCL 50MG TABSA273405074B411119A
TRAMADOL HCL 50MG TABSA273405079A412092A
TRAMADOL HCL 50MG TABSA273406001A412093A
TRAMADOL HCL 50MG TABSA273406002A412094A
TRAMADOL HCL 50MG TABSA273406003A412095A
TRAMADOL HCL 50MG TABSA273408208A412096A
TRAMADOL HCL 50MG TABSA273408209A412096A
TRAMADOL HCL 50MG TABSA273410133A502111A
TRAMADOL HCL 50MG TABSA273410134A502112A
TRAMADOL HCL 50MG TABSA273410135A410136A
TRAMADOL HCL 50MG TABSA273410179A410137A
TRAMADOL HCL 50MG TABSA273410181A410138A
TRAMADOL HCL 50MG TABSA273410178A410180A
    
Major Label - Private Label Manufactured by Able LabsImprintLot #Lot #
LITHIUM CARBONATE CAP 300mgA270307172A 
LITHIUM CARBONATE CAP USPA270307172A 
LITHIUM CARBONATE CAP 300mgA270310089A 
PROPOXYPHENE NAPSYLATE/ APAPA256307266A 
    
Hawthorn Label - Private Label Manufactured by Able LabsImprintLot #Lot #
Dytan- Suspension L409001A 
Dytan- Suspension L409002A 
Dytan-D Suspension L412001A 
Dytan-D Suspension L401007 
Dytan-D Suspension L401008 
Dytan-D Suspension L401009 
Dytan-D Suspension L401009 
Dytan-D Suspension L401010 
Dytan-D Suspension L401010 
Dytan-D Suspension L403002 
Dytan-D Suspension L404002 
Dytan-D Suspension L404002 
Dytan-D Suspension L404003 
Dytan-D Suspension L404003 
Dytan-D Suspension L404004 
Dytan-D Suspension L404004 
Dytan-D Suspension L404005 
Dytan-D Suspension L404005 
    
Cypress Label - Private Label Manufactured by Able LabsImprintLot #Lot #
Liqui- Stride Concentrate L402003 
Liqui- Stride Concentrate L402004 
Andehist-NR Syrup 3L04 
Andehist-NR Syrup 3L04 
Andehist-NR Syrup 3L05 
Andehist-NR Syrup L401002 
Andehist-NR Oral Drop 3L07 
Andehist-NR Oral Drop 3L08 
Andehist-NR Oral Drop 3L08 
Andehist-NR Oral Drop 3L02 
Andehist-NR Oral Drop 3L02 
Andehist-NR Oral Drop 3L03 
Andehist-NR Oral Drop L401001 
Bromhist-DM Drops 3L06 
Bromhist-DM Drops 3L06 
    
Breckenridge Label - Private Label Manufactured by Able LabsImprintLot #Lot #
Quad Tann Pediatric Suspension 3L01 


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. An investigation is underway to identify all the repackers and wholesalers who distribute these drugs from Able Laboratories. In the meantime, the best way for consumers to know whether they have a product produced by Able Laboratories is to check the list below and either contact their pharmacist or compare the imprint numbers on their individual tablets with the imprint numbers listed on the FDA website.

Consumers with questions may contact Able Laboratories at 1-800-982-2253. Persons wanting to report any adverse events to the FDA may contact FDA’s MedWatch office at 1-800-FDA-1088.

#
 

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