Expiration date extensions of certain lots of doxycycline hyclate capsules
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
[2/1/2023] 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.
Based 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. 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’ 2020 and 2018 expiration dating extensions.
Additional information can be found in FDA’s February 1, 2023, memorandum (PDF, 221 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). FDA also authorized expiration dating extensions of other lots of doxycycline held in strategic stockpiles in a September 3, 2015, memorandum (PDF, 28 KB).
Please contact FDA at DoxycyclineExpirationExtensionRequest@fda.hhs.gov with questions regarding these extensions.
West-Ward doxycycline hyclate 100-mg capsules eligible for use beyond the manufacturer’s labeled expiration date (February 1, 2023)
| Doxycycline Lot Number (West-Ward) | Manufacturer’s Original Labeled Expiry Date | 1st Extension: New Use Date (Issued on August 22, 2018) | 2nd Extension: New Use Date (Issued on August 7, 2020) | 3rd Extension Request (September 2022): No Extension (January 2023) |
|---|---|---|---|---|
| 68788A | March 31, 2015 | June 30, 2020 | July 31, 2022 | N/A |
| GS008914 | March 31, 2018 | June 30, 2020 | July 31, 2022 | N/A |
| GS008915 | March 31, 2018 | June 30, 2020 | July 31, 2022 | N/A |
| GS008916 | April 30, 2018 | June 30, 2020 | July 31, 2022 | N/A |
| GS008917 | April 30, 2018 | June 30, 2020 | July 31, 2022 | N/A |