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FOR IMMEDIATE RELEASE |
Media Inquiries:Brad Stone |
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.
| 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 APAP 5-500 MG TAB |
500 |
A329 |
|
| HYDROCODONE BITARTRATE APAP 7.5-325 MG TAB |
100 |
A335 |
|
| HYDROCODONE BITARTRATE APAP 7.5-325 MG TAB |
500 |
A335 |
|
| HYDROCODONE BITARTRATE APAP 7.5-500 MG TAB |
100 |
A330 |
|
| HYDROCODONE BITARTRATE APAP 7.5-500 MG TAB |
500 |
A330 |
|
| HYDROCODONE BITARTRATE APAP 7.5-650 MG TAB |
100 |
A332 |
|
| HYDROCODONE BITARTRATE APAP 7.5-650 MG TAB |
500 |
A332 |
|
| HYDROCODONE BITARTRATE APAP 7.5-750 MG TAB |
100 |
A334 |
|
| HYDROCODONE BITARTRATE APAP 7.5-750 MG TAB |
500 |
A334 |
|
| HYDROCODONE BITARTRATE APAP 10-325 MG TAB |
100 |
A328 |
|
| HYDROCODONE BITARTRATE APAP 10-325 MG TAB |
500 |
A328 |
|
| HYDROCODONE BITARTRATE APAP 10-500 MG TAB |
100 |
A331 |
|
| HYDROCODONE BITARTRATE APAP 10-500 MG TAB |
500 |
A331 |
|
| HYDROCODONE BITARTRATE APAP 10-650 MG TAB |
100 |
A333 |
|
| HYDROCODONE BITARTRATE APAP 10-650 MG TAB |
500 |
A333 |
|
| HYDROCORTISONE ACETATE 25 MG SUPP |
12 |
AL0761F/02(foil) |
|
| HYDROCORTISONE ACETATE 25 MG SUPP |
24 |
AL0761F/02(foil) |
|
| HYDROXYZINE HCL 10 MG TAB |
100 |
A |
387 |
| HYDROXYZINE HCL 10 MG TAB |
500 |
A |
387 |
| HYDROXYZINE HCL 10 MG TAB |
1000 |
A |
387 |
| HYDROXYZINE HCL 25 MG TAB |
100 |
A |
388 |
| HYDROXYZINE HCL 25MG TAB |
500 |
A |
388 |
| HYDROXYZINE HCL 25 MG TAB |
1000 |
A |
388 |
| HYDROXYZINE HCL 50 MG TAB |
100 |
A |
389 |
| HYDROXYZINE HCL 50 MG TAB |
500 |
A |
389 |
| HYDROXYZINE HCL 50 MG TAB |
1000 |
A |
389 |
| INDOMETHACIN 25 MG CAP |
100 |
267 |
A |
| INDOMETHACIN 25 MG CAP |
1000 |
267 |
A |
| INDOMETHACIN 50 MG CAP |
100 |
268 |
A |
| INDOMETHACIN 50 MG CAP |
500 |
268 |
A |
| INDOMETHACIN ER 75 MG CAP |
60 |
A |
269 |
| INDOMETHACIN ER 75 MG CAP |
100 |
A |
269 |
| LITHIUM CARBONATE 150 MG CAP |
100 |
A |
355 |
| LITHIUM CARBONATE 150 MG CAP |
500 |
A |
355 |
| LITHIUM CARBONATE 300 MG CAP |
100 |
A |
270 |
| LITHIUM CARBONATE 300 MG CAP |
1000 |
A |
270 |
| LITHIUM CARBONATE ER 300 MG TAB |
100 |
A283 |
|
| LITHIUM CARBONATE 600 MG CAP |
100 |
A |
356 |
| METHAMPHETAMINE 5 MG TAB CII |
100 |
A396 |
|
| METHOCARBAMOL 500 MG TAB |
100 |
A265 |
|
| METHOCARBAMOL 500 MG TAB |
500 |
A265 |
|
| METHOCARBAMOL 750 MG TAB |
100 |
A264 |
|
| METHOCARBAMOL 750 MG TAB |
500 |
A264 |
|
| METHYLPHENIDATE HCl 5 MG TAB CII |
100 |
A |
253 |
| METHYLPHENIDATE HCl 5 MG TAB CII |
1000 |
A |
253 |
| METHYLPHENIDATE HCl 10 MG TAB CII |
100 |
A |
254 |
| METHYLPHENIDATE HCl 10 MG TAB CII |
1000 |
A |
254 |
| METHYLPHENIDATE HCl 20 MG TAB CII |
100 |
A |
255 |
| METHYLPHENIDATE HCl 20 MG TAB CII |
1000 |
A |
255 |
| METHYLPHENIDATE HCl ER 20 MG TAB CII |
100 |
A262 |
|
| METHYLPHENIDATE HCl ER 20 MG TAB CII |
1000 |
A262 |
|
| METRONIDAZOLE 250 MG TAB |
100 |
A374 |
|
| METRONIDAZOLE 250 MG TAB |
250 |
A374 |
|
| METRONIDAZOLE 250 MG TAB |
500 |
A374 |
|
| METRONIDAZOLE 500 MG TAB |
60 |
A375 |
|
| METRONIDAZOLE 500 MG TAB |
100 |
A375 |
|
| METRONIDAZOLE 500 MG TAB |
500 |
A375 |
|
| METRONIDAZOLE ER 750 MG TAB |
30 |
A352 |
|
| METRONIDAZOLE 375 MG CAP |
50 |
A |
353 |
| NAPROXEN SODIUM 275 MG TAB |
100 |
A363 |
|
| NAPROXEN SODIUM 275 MG TAB |
500 |
A363 |
|
| NAPROXEN SODIUM 550 MG TAB |
100 |
A364 |
|
| NAPROXEN SODIUM 550 MG TAB |
500 |
A364 |
|
| NITROGLYCERIN SUBLINGUAL 0.3 MG SL TAB |
100 |
1 |
|
| NITROGLYCERIN SUBLINGUAL 0.4 MG SL TAB |
100 |
2 |
|
| NITROGLYCERIN SUBLINGUAL 0.4 MG SL TAB |
4X25 |
2 |
|
| NITROGLYCERIN SUBLINGUAL 0.6 MG SL TAB |
100 |
3 |
|
| PHENAZOPYRIDINE HCl 100 MG TAB |
100 |
AP1 |
|
| PHENAZOPYRIDINE HCl 100 MG TAB |
1000 |
AP1 |
|
| PHENAZOPYRIDINE HCl 200 MG TAB |
100 |
AP2 |
|
| PHENAZOPYRIDINE HCl 200 MG TAB |
1000 |
AP2 |
|
| PHENTERMINE POWDER 15 MG CAP |
100 |
A |
346 |
| PHENTERMINE POWDER 15 MG CAP |
1000 |
A |
346 |
| PHENTERMINE BEADS 30 MG CAP |
100 |
A |
259 |
| PHENTERMINE BEADS 30 MG CAP |
1000 |
A |
259 |
| PHENTERMINE POWDER 30 MG CAP |
100 |
A |
258 |
| PHENTERMINE POWDER 30 MG CAP |
1000 |
A |
258 |
| PHENTERMINE 37.5 MG TAB |
100 |
A257 |
|
| PHENTERMINE 37.5 MG TAB |
1000 |
A257 |
|
| PROCHLORPERAZINE 2.5 MG SUPP |
12 |
AL0762F |
|
| PROCHLORPERAZINE 5 MG SUPP |
12 |
AL0763F |
|
| PROCHLORPERAZINE 25 MG SUPP |
12 |
AL0746F |
|
| PROMETHAZINE 12.5MG SUPP |
12 |
AL0765/01 |
|
| PROMETHAZINE 25 MG SUPP |
12 |
AL0766F/01 |
|
| PROMETHAZINE 50 MG SUPP |
12 |
AL0767F/01 |
|
| PROMETHAZINE TABLETS 12.5 MG TAB |
100 |
A405 |
|
| PROMETHAZINE TABLETS 25 MG TAB |
100 |
A406 |
|
| PROMETHAZINE TABLETS 25 MG TAB |
1000 |
A406 |
|
| PROMETHAZINE TABLETS 50 MG TAB |
100 |
A407 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
100 |
A256 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
500 |
A256 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
1000 |
A256 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
100 |
A261 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
500 |
A261 |
|
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
1000 |
A261 |
|
| SALSALATE 500 MG TAB |
100 |
A500 |
|
| SALSALATE 500 MG TAB |
500 |
A500 |
|
| SALSALATE 750 MG TAB |
100 |
A750 |
|
| SALSALATE 750 MG TAB |
500 |
A750 |
|
| THEOPHYLLINE ER 400 MG TAB |
100 |
A380 |
|
| THEOPHYLLINE ER 400 MG TAB |
500 |
A380 |
|
| THEOPHYLLINE ER 600 MG TAB |
100 |
A382 |
|
| Ivax Label -Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306060A |
402154A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306061A |
402155A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306062A |
402156A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306063A |
402157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306063A |
402158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306064A |
402158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306065A |
402159A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306066A |
402166A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306067A |
402167A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306068A |
402168A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306068A |
402169A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306069A |
402170A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306070A |
403001A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306071A |
403002A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306072A |
403003A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306073A |
403004A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
306074A |
403005A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307011A |
403006A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307012A |
403007A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307013A |
403008A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307014A |
403009A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307015A |
403010A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307016A |
403099A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307017A |
403100A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307018A |
403101A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307019A |
403102A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307019A |
403103A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307020A |
403104A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307126A |
403105A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307127A |
403106A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307128A |
403107A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307129A |
403107A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307130A |
403108A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307131A |
403108A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307132A |
403157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307133A |
403157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307134A |
403157A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307135A |
403158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307296A |
403158A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307297A |
403159A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307298A |
403160A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
307299A |
403161A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309013A |
403164A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309014A |
403165A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309015A |
403166A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309016A |
403167A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309017A |
403168A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309018A |
404046A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
309019A |
404047A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310113A |
404047A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310114A |
404048A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310115A |
404049A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310116A |
404050A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
310117A |
404087A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312011A |
404088A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312011A |
404089A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312012A |
404090A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312013A |
404091A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312013A |
404105A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312014A |
404106A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312014A |
404107A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312015A |
404108B |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312015A |
404108B |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312021A |
404109A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312022A |
404109A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312023A |
406116A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312024A |
406116A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312024A |
406117A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312025A |
406117A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312141A |
406118A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312142A |
406118A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312143A |
406119A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312144A |
406119A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312144A |
406120A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
312145A |
406121A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401077A |
406122A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401078A |
406123A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401079A |
406124A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401080A |
406125A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
401081A |
410059A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402047A |
410060A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402048A |
410061A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402049A |
410062A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402050A |
410063A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402051A |
410064A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402069A |
410065A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402069A |
410065A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402070A |
410066A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402071A |
410067A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402072A |
410068A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402073A |
411030A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402150A |
411031A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402151A |
411032A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402152A |
411033A |
| PROPOXYPHENE NAPS/APAP 100-650 MG TAB |
Z4980 |
402153A |
411034A |
| 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 TABS |
A273 |
401174A |
405046A |
| TRAMADOL HCL 50MG TABS |
A273 |
401175A |
405047A |
| TRAMADOL HCL 50MG TABS |
A273 |
401176A |
405048A |
| TRAMADOL HCL 50MG TABS |
A273 |
401177A |
405049A |
| TRAMADOL HCL 50MG TABS |
A273 |
401178A |
405050A |
| TRAMADOL HCL 50MG TABS |
A273 |
402161A |
405075A |
| TRAMADOL HCL 50MG TABS |
A273 |
402162A |
405076A |
| TRAMADOL HCL 50MG TABS |
A273 |
402163A |
405077A |
| TRAMADOL HCL 50MG TABS |
A273 |
402164A |
405078A |
| TRAMADOL HCL 50MG TABS |
A273 |
405070A |
410182A |
| TRAMADOL HCL 50MG TABS |
A273 |
405071A |
411115A |
| TRAMADOL HCL 50MG TABS |
A273 |
405072A |
411116A |
| TRAMADOL HCL 50MG TABS |
A273 |
405073A |
411117A |
| TRAMADOL HCL 50MG TABS |
A273 |
405074B |
411119A |
| TRAMADOL HCL 50MG TABS |
A273 |
405079A |
412092A |
| TRAMADOL HCL 50MG TABS |
A273 |
406001A |
412093A |
| TRAMADOL HCL 50MG TABS |
A273 |
406002A |
412094A |
| TRAMADOL HCL 50MG TABS |
A273 |
406003A |
412095A |
| TRAMADOL HCL 50MG TABS |
A273 |
408208A |
412096A |
| TRAMADOL HCL 50MG TABS |
A273 |
408209A |
412096A |
| TRAMADOL HCL 50MG TABS |
A273 |
410133A |
502111A |
| TRAMADOL HCL 50MG TABS |
A273 |
410134A |
502112A |
| TRAMADOL HCL 50MG TABS |
A273 |
410135A |
410136A |
| TRAMADOL HCL 50MG TABS |
A273 |
410179A |
410137A |
| TRAMADOL HCL 50MG TABS |
A273 |
410181A |
410138A |
| TRAMADOL HCL 50MG TABS |
A273 |
410178A |
410180A |
| Major Label - Private Label Manufactured by Able Labs |
Imprint |
Lot # |
Lot # |
| LITHIUM CARBONATE CAP 300mg |
A270 |
307172A |
|
| LITHIUM CARBONATE CAP USP |
A270 |
307172A |
|
| LITHIUM CARBONATE CAP 300mg |
A270 |
310089A |
|
| PROPOXYPHENE NAPSYLATE/ APAP |
A256 |
307266A |
|
| Hawthorn Label - Private Label Manufactured by Able Labs |
Imprint |
Lot # |
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 Labs |
Imprint |
Lot # |
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 Labs |
Imprint |
Lot # |
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.
####
Quality Care Products L.L.C. Recall (June 15, 2005)
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