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Compounding Antibiotic Recalled

July 12, 2017

American Pharmaceutical Ingredients LLC is voluntarily recalling 23.5 kg of doxycycline hyclate USP, active pharmaceutical ingredient for prescription compounding, according to the July 5, 2017, US Food and Drug Administration (FDA) Enforcement Report.

“Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient,” the FDA reported.

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The recall affects lot 082815-1, which has an expiration of June 4, 2019. The doxycycline hyclate was distributed nationwide and packaged as follows:

  • 25 g packaged in a 500-cc container,
  • 100 g packaged in a 16-oz container,
  • 500 g packaged in a 2500-cc container, and
  • 1,000 g packaged in 1-gallon container.

The company issued the recall June 1, 2107. On June 29, 2017, the FDA designated it Class II, which is used for situations when exposure to the recalled product could cause temporary or medically reversible adverse health consequences, or when the probability of serious health effects is remote.

Doxycycline hyclate is a tetracycline antibiotic.

Jolynn Tumolo

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