Requests that the FDA recall on identified lots of Acetazolamide tor injection on the basis that, due to under-potency and excessive impurities in some vials, these drugs are adulterated under Section 501 of the FDCA (21 U.S.C. § 351) and misbranded under Section 502 of the FDCA (21 U.S.C. § 352); conduct examinations and investigation provide information to the public promulgate regulations.
🏛 Food and Drug Administration (FDA)FDA-2020-P-2033
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