Multi-event July 2018 FDA Recall Doxycycline Hyclate by West-ward Columbus Inc
This Multi-event Class II drug recall was voluntarily initiated by West-ward Columbus Inc on July 24, 2018 for the product Doxycycline Hyclate. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1025-2018
Failed Dissolution Specifications:
07-24-2018
08-08-2018
29048 500-count bottles (14,524,000 tablets)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.
Batch or Lot Expiration Information
Lot# 71545A, Expiry date: 07/19
Affected Packages Involved in this Recall
Recall Number: D-1024-2018
Failed Dissolution Specifications:
07-24-2018
08-08-2018
29,048 bottles (1,452,400 tablets)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
Batch or Lot Expiration Information
Lot# 71545B, Expiry date: 01/19
