![]() FDA also authorized expiration dating extensions of other lots of doxycycline held in strategic stockpiles in a September 3, 2015, memorandum (PDF, 28 KB). FDA extended the expiration dates of these same lots in an August 7, 2020, memorandum (PDF, 86 KB) and an August 22, 2018, memorandum (PDF, 291 KB). The memo also provides information for other government stakeholders that properly hold any of the same lots of doxycycline hyclate 100 mg capsules listed in the memo and have relied on these lots’ 20 expiration dating extensions.Īdditional information can be found in FDA’s February 1, 2023, memorandum (PDF, 221 KB). ![]() FDA is alerting government public health and emergency response stakeholders of an important update about certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals (West-Ward) held in strategic stockpiles for anthrax emergency preparedness and response purposes that were granted expiration dating extensions by FDA in August 2020 and August 2018 based on the guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.īased on data submitted to FDA in a stakeholder request, FDA has concluded that the test results for the five (5) lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward that are identified in FDA’s February 1, 2023, memorandum (PDF, 221 KB) do not support an additional expiration date extension because degradants exceeded acceptable limits as described in the guidance. ![]() FDA alerts government public health and emergency response stakeholders of an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |