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

[8/7/2020] 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. 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 7, 2020, memorandum (PDF, 86 KB). FDA extended the expiration dates of these same lots in 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).

FDA is not requiring or recommending that the identified lots in the following table be relabeled with their new use dates.

Please contact Brad Leissa at [email protected] or Brooke Courtney at [email protected] with questions regarding these extensions.

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 [email protected] or Brooke Courtney at [email protected] with questions regarding these extensions.

West-Ward doxycycline hyclate 100-mg capsules eligible for use beyond the manufacturer’s labeled expiration date (August 7, 2020)

Related Links

• Expiration Dating Extension