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Expiration date extensions of certain lots of doxycycline hyclate capsules

FDA alerts government public health and emergency response stakeholders of expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals

[8/22/2018] FDA is alerting government public health and emergency response stakeholders of dates through which certain lots of doxycycline hyclate 100 mg capsules, manufactured by West-Ward Pharmaceuticals, may be used beyond the manufacturer’s labeled expiration date. All such lots are listed in the following table. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.

Additional information about these expiration dating extensions, including any applicable requirements and conditions for stockpiling and emergency use of the authorized lots of doxycycline, can be found in FDA’s August 22, 2018, memorandum (PDF, 286 KB). The table below also includes certain lots of West-Ward doxycycline product held in strategic stockpiles for which FDA authorized expiration dating extensions in a September 3, 2015, memorandum (PDF, 28 KB). FDA is not requiring or recommending that the identified lots in the following table be relabeled with their new use dates.

Government stakeholders are encouraged to have their doxycycline product that is held beyond the manufacturer labeled expiration date tested under the guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. [Note: this guidance was finalized on April 24, 2019.]. Any future extensions under the guidance, if requested by a government stakeholder and authorized by FDA, will be posted on the FDA website.

Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@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 (August 22, 2018)
 Doxycycline Lot Number (West-Ward)  Manufacturer’s Original Expiry Date  New Use Date
August 22, 2018, Extension:
 68788A  March 31, 2015  June 30, 2020
 GS008914  March 31, 2018  June 30, 2020
 GS008915  March 31, 2018  June 30, 2020
 GS008916  April 30, 2018  June 30, 2020
 GS008917  April 30, 2018  June 30, 2020
September 3, 2015, Extension:
 65503A  August 31, 2012  October 31, 2016
 66058A  December 31, 2012  October 31, 2016
 66639A  April 30, 2013  October 31, 2016
 66648A  April 30, 2013  October 31, 2016
 69833A  March 31, 2016  March 31, 2018
 69834A  April 30, 2016  April 30, 2018

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