Class II
Terminated
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.
This recall has been terminated (originally issued June 10, 2020).
- Company
- The Harvard Drug Group
- Recall Initiated
- May 22, 2020
- Posted
- June 10, 2020
- Recall Number
- D-1288-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,443 cartons
- Firm Location
- Livonia, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: a) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020
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