May 2020 FDA Recall Doxycycline Hyclate by West-ward Columbus Inc
D-1274-2020 - Failed dissolution specification

This Class II drug recall was voluntarily initiated by West-ward Columbus Inc on May 13, 2020 for the product Doxycycline Hyclate. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1274-2020

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.
Initiated
05-13-2020
Reported
06-03-2020
Quantity
68,376 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85555
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
West-Ward Columbus Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-25-2023
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

0143-2112-50 Doxycycline Hyclate
0143-2112-05 Doxycycline Hyclate
0143-2112-20 Doxycycline Hyclate