Doxycycline Hyclate Tablet, Coated
FDA Recall NDC 0143-2112
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Doxycycline Hyclate (NDC 0143-2112). A significant event, classified as Class II, was initiated on May 13, 2020 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
May 13, 2020
Jun 03, 2020
68,376 bottles
Recall Profile & Regulatory Data
Event ID
85555
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Columbus Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Mar 25, 2023
Product Description
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
0143-2112-50Product
0143-2112-05Product
0143-2112-20Product
Class II Terminated
Failed Dissolution Specifications:
Jul 24, 2018
Aug 08, 2018
29048 500-count bottles (14,524,000 tablets)
Recall Profile & Regulatory Data
Event ID
80364
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Columbus Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Apr 29, 2020
Product Description
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
0143-2112-50Product
0143-2112-05Product
0143-2112-20Product
Class II Terminated
Failed Dissolution Specifications:
Jul 24, 2018
Aug 08, 2018
29,048 bottles (1,452,400 tablets)
Recall Profile & Regulatory Data
Event ID
80364
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Columbus Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Apr 29, 2020
Product Description
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
Affected Packages Involved in this Recall
0143-2112-50Product
0143-2112-05Product
0143-2112-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
