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Guidance for industry and FDA staff. Comments can be submitted.
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May 21st, 2021
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
This guidance describes the Agency s policy regarding the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages set forth at 21 CFR 801.57(a)-(b). As described below, FDA does not intend to object to the use of legacy FDA identification numbers on device labels and packages for finished devices manufactured and labeled prior to September 24, 2023. In addition, this guidance addresses requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs).
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Extra Strength Acetaminophen Recalled
Nearly 200,000 bottles of extra-strength acetaminophen, used to relieve pain and fevers and sold under multiple brand names, are being recalled nationwide due to a mislabeling issue.
A-S Medication Solutions, LLM voluntarily recalled bottles of its Acetaminophen Extra Strength 500 mg tablets because they have an incomplete prescription drug label rather than the required OTC Drug Facts label, the Food and Drug Administration (FDA) said in a notice.
Representatives for A-S Medication Solutions did not return FOX Business request for comment. Acetaminophen could be potentially harmful if safety warnings contained on the OTC label are not observed, the FDA said.
Extra-strength acetaminophen recalled nationwide
Courtesy of FDA
Nearly 200,000 bottles of extra-strength acetaminophen, used to relieve pain and fevers and sold under multiple brand names, are being
recalled nationwide due to a mislabeling issue.
A-S Medication Solutions, LLM voluntarily recalled bottles of its Acetaminophen Extra Strength 500 mg tablets because they have an incomplete prescription drug label rather than the required OTC Drug Facts label, the Food and Drug Administration (FDA) said in a notice.
Representatives for A-S Medication Solutions did not return FOX Business request for comment.
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The proper label is supposed to include warnings about liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or if consumers are allergic to the active ingredient.
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