November 9, 2019

Recalls Impacting Workers’ Comp

Last month, Healthesystems reported on several companies issuing recalls for ranitidine hydrochloride due to confirmed contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

Ranitidine hydrochloride capsules are indicated for the treatment of duodenal ulcer, benign ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.

Relevant to workers’ comp, patients taking opioid pain medications may experience gastrointestinal side effects, requiring a gastrointestinal agent and potentially be prescribed ranitidine hydrochloride.

The recalls began in September with Sandoz Inc, followed later by Sanofi, Perrigo, and Dr. Reddys. However, even more companies have issued recalls for ranitidine hydrochloride.

Novitum PharmaAmneal PharmaceuticalsApotexAurobindo PharmaGolden State Medical SupplyWalgreens, and Kroger have all issued nationwide recalls for ranitidine hydrochloride tablets. Meanwhile Lannett Company, Inc. is recalling ranitidine syrup for similar impurities of NDMA, as is American Health Packaging.

Furthermore, the FDA is now advising other companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake. In addition to ranitidine, FDA is also requesting manufacturers test and potentially recall nizatidine, commonly known as Axid, if NDMA levels are above acceptable daily intake levels due to chemical similarities.

In other news, Mylan Pharmaceuticals Inc. is recalling one lot of alprazolam tablets due to the potential presence of foreign substance, which can cause infection.

Alprazolam tables are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia. Mental health medications are not uncommon in workers’ comp claims, especially if workplace injuries reduce physical function and cause mental stress.

The recall specifically targets a bottle of 500 USP C-IV 0.5 mg tablets of alprazolam, lot number 8082708, with an expiration date of September 2020, and an NDC of 0378-4003-05.

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