FDAClass IIJune 3, 2020

Doxycycline Hyclate Tablets USP recall: Failed Dissolution

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

Why was Doxycycline Hyclate Tablets USP recalled?

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021

Product
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Recalling firm
West-Ward Columbus Inc
Quantity
68,376 bottles
Distribution
USA Nationwide
Recall date
June 3, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls