Medicine recalls
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| The United States: Sandoz Inc. issues nationwide recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release Tablets due to presence of a nitrosamine impurity |
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The US Food and Drug Administration (FDA) announces that Sandoz Inc. is initiating a voluntary recall of 13 lots of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level (lot number: JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, LA9243). The presence of a nitrosamine impurity, N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or nitroso-orphenadrine), which has the potential to be above the FDA’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing.
Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lots.
This recall of Orphenadrine Citrate 100 mg ER Tablets is specific to the lots listed above and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Mar 23, 2022
Issued at HKT 15:30
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