Reported Jun 10, 2020 · Terminated
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit…
The Harvard Drug Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group · 17177 N Laurel Park Dr Ste 233 · Livonia, MI · 48152-3951
Is this the product you have?
- 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
- byWest-Ward Pharmaceutical Corp., Eatontown, NJ 07724
- Distributed by
Major Pharmaceuticals17177 N. Laurel Park DrSuite 233LivoniaMI 48152
- Lot codes and dates
Lot #: a) R00828DExp. date 08/2020b) R00732DExp. date 05/2020R00783DExp. date 06/2020R00827DExp. date 08/2020
- Amount recalled
- 16,443 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
This product could cause temporary or reversible health problems — stop using it.
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