Doxycycline Tablet, Coated
FDA Recall NDC 55289-866
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 55289-866). A significant event, classified as Class II, was initiated on May 15, 2020 by Pd-rx Pharmaceuticals, Inc.. The reported reason for this action was: "Failed dissolution specifications"
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 specifications
May 15, 2020
Jun 03, 2020
14,030 bottles
Recall Profile & Regulatory Data
Event ID
85724
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Nov 08, 2021
Product Description
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Batch or Lot Expiration Information
Lot# Lots: a) L18B72, Exp 12/31/2020; b)I18B83, Exp 06/30/2020 ; c) H18B11, Exp 06/30/2020; I18A53, Exp 06/30/2020; J18F97, Exp 10/31/2020; K18A33, Exp 11/30/2020; K18D17, Exp 11/30/2020; L18A11, Exp 12/31/2020; L18A29, Exp 12/31/2020; L18D81, Exp 12/31/2020; d) H18F60, Exp 06/30/2020; I18C26, Exp 06/30/2020; I18D61, Exp. 06/30/2020; J18B80, Exp 10/31/2020; K18C97 Exp 11/30/2020; L18B30, Exp. 12/31/2020; L18D25, Exp 12/31/2020; L18E50 Exp 12/31/2020; e) I18D07, Exp. 06/30/2020; J1E02, Exp 10/31/2020; J18E62 Exp 10/31/2020; K18E98 Exp. 11/30/2020; L18C54, Exp 12/31/2020; f) H18E18 Exp. 06/30/2020, I18F94 Exp. 09/30/2020, J18E42, Exp. 10/31/2020, L18B56 Exp. 12/31/2020; g) J18C84 Exp. 10/31/2020, A19B70 Exp. 01/31/2021; h) K18E92 Exp. 11/30/2020; i) I18E80 Exp. 06/30/2020, K18A19 Exp. 11/30/2020; j) F18E11 Exp. 06/30/2020, G18E66 Exp. 06/30/2020, H18E72 Exp. 06/30/2020, I18E75 Exp. 09/30/2020, I18E95 Exp. 09/30/2020, I18F64 Exp. 09/30/2020; k) A19D44 Exp. 08/31/2020, H18E76 Exp. 06/30/2020, I18F21 Exp. 09/30/2020, L18B91 Exp. 12/31/2020
Affected Packages Involved in this Recall
55289-866-02Product
55289-866-04Product
55289-866-06Product
55289-866-07Product
55289-866-10Product
55289-866-20Product
55289-866-28Product
55289-866-30Product
55289-866-50Product
55289-866-60Product
55289-866-71Product
55289-866-74Product
55289-866-85Product
55289-866-86Product
55289-866-87Product
55289-866-90Product
55289-866-93Product
55289-866-98Product
55289-866-01Product
55289-866-82Product
55289-866-95Product
55289-866-14Product
Class II Terminated
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Aug 07, 2018
Sep 05, 2018
6,641 bottles
Recall Profile & Regulatory Data
Event ID
80791
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
May 07, 2020
Product Description
Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.
Batch or Lot Expiration Information
Lot# : a) D17D29, L17C73, F18E73, Exp. 1/31/19; b) H17D70, K17F66, G18F26, Exp. 1/31/19; c) C18G26, F18E36, Exp. 1/31/19; d) F18A85, Exp. 1/31/19; e) K17B44, K17E29, L17D93, Exp. 1/31/19; E17B88, Exp. 5/31/19; H17A52, H17D67, Exp. 7/31/19; f) E17B01, E17E83, Exp. 5/31/19; F17C99, Exp. 6/30/19; G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, Exp. 7/31/19; g) E17E27, Exp. 1/31/19, I17A33, G17D62, Exp. 7/31/19; h) E17B35, E17D90, Exp. 5/31/19, F17C13, Exp. 6/30/19, G17B25, H17C58, Exp. 7/31/19; i) G17D59, Exp. 7/31/19; j) I17A69, G17D58, Exp. 7/31/19; k) G17D56, Exp. 7/31/19.
Affected Packages Involved in this Recall
55289-866-02Product
55289-866-04Product
55289-866-06Product
55289-866-07Product
55289-866-10Product
55289-866-20Product
55289-866-28Product
55289-866-30Product
55289-866-50Product
55289-866-60Product
55289-866-71Product
55289-866-74Product
55289-866-85Product
55289-866-86Product
55289-866-87Product
55289-866-90Product
55289-866-93Product
55289-866-98Product
55289-866-01Product
55289-866-82Product
55289-866-95Product
55289-866-14Product
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.
