Doxycycline Tablet, Coated
FDA Recall NDC 62584-693
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Doxycycline (NDC 62584-693). A significant event, classified as Class II, was initiated on May 19, 2020 by American Health Packaging. The reported reason for this action was: "Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life)."
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
May 2020 Class II Recall: Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Recall Number
Class II Terminated
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
May 19, 2020
Jun 17, 2020
15,755 cartons
Recall Profile & Regulatory Data
Event ID
85745
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Aug 03, 2022
Product Description
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
Batch or Lot Expiration Information
Lot# Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021
Affected Packages Involved in this Recall
62584-693-11Product
62584-693-21Product
Class II Terminated
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Aug 01, 2018
Aug 07, 2019
6,579 cartons
Recall Profile & Regulatory Data
Event ID
83466
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 30, 2020
Product Description
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
Batch or Lot Expiration Information
Lot# Lot 172569, Exp 7/31/2019
Affected Packages Involved in this Recall
62584-693-11Product
62584-693-21Product
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.
