FDA: Able Labs Recalls All Drugs

Able Laboratories has recalled all of its products, most of which are generic drugs, says the FDA.

The recall is due to “serious concerns that [the drugs] were not produced according to quality assurance standards,” says an FDA news release.

People who have been taking drugs produced by Able Laboratories are advised to speak with their health care provider or pharmacist to get a replacement drug product, says the FDA’s Margaret O’K. Glavin, in a news release.

“Consumers should continue taking the medication until they have spoken with their health care provider,” says Glavin, the FDA’s associate commissioner for regulatory affairs. “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.”

Only Able’s Products Recalled

The recall only applies to products made by Able Laboratories. Generic versions of the same drugs made by other manufacturers are not affected.

A generic medicine’s label may or may not disclose the maker’s name, says Atlanta pharmacist Jay Largent. Largent, who works for Eckerd Drugs, suggests that patients call the pharmacy that filled their prescription. That pharmacy “should know whether the product was an Able product,” Largent tells WebMD.

Recalled Able Drugs

Acetaminophen & codeine tablets
Atenolol tablets
Bethanechol chloride tablets
Butalbital/APAP/caffeine tablets
Butalbital/APAP/caffeine/codeine caplets
Carisoprodol tablets
Clorazepate dipotassium tablets
Diphenoxylate/atropine tablets
Hydrocodone bitartrate APAP tablets
Hydrocortisone acetate suppositories
Hydroxyzine HCL tablets
Indomethacin caplets
Lithium carbonate caplets
Lithium carbonate ER tablets
Methamphetamine tablets
Methocarbamol tablets
Methylphenidate HCL tablets
Methylphenidate HCL ER tablets
Metronidazole tablets and caplets
Metronidazole ER tablets
Naproxen sodium tablets
Nitroglycerin sublingual tablets
Phenazopyridine HCL tablets
Phentermine powder caplets
Phentermine beads caplets
Prochlorperazine suppositories
Promethazine suppositories and tablets
Propoxyphene NAPS/APAP tablets
Salsalate tablets
Theophylline ER tablets

Recalled Drugs Made by Able for the “Ivax” Label

Propoxyphene NAPS/APAP tablets
Tramadol HCL tablets and blisters

Recalled Drugs Made by Able for “Major” Label

Lithium carbonate caplets
Propoxyphene Napsylate/APAP

Recalled Drugs Made by Able for “Hawthorne” Label

Dytan Suspension
Dytan-D Suspension

Recalled Drugs Made by Able for “Cypress” Label

Liqui-Stride Concentrate
Andehist-NR Syrup
Andehist-NR Oral Drops
Bromhist-DM Drops

Recalled Drugs Made by Able for “Breckenridge” Label

Quad Tann Pediatric Suspension

The FDA’s web site has detailed listings on each drug’s size and imprints. As for Able Laboratories, the company’s web site says the firm has stopped production and cut its staff by about 200 people. Chairman and CEO Dhananjay G. Wadekar announced his resignation earlier in May, says Able. WebMD’s calls to Able were not returned.

By Miranda Hitti, reviewed by Brunilda Nazario, MD

SOURCES: News release, FDA. Able Laboratories, “Urgent Product Recall -- Able Laboratories Inc -- All Products.” News releases, Able Laboratories.