FDAFDA · Food and drugs·Recall number D-1288-2020
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
Published June 10, 2020 · Recall initiated: May 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group
- Distributor
- Nationwide within the United States
- Lot
- Lot #: a) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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