May 2020 FDA Recall Doxycycline by Pd-rx Pharmaceuticals, Inc.
D-1276-2020 - Failed dissolution specifications
This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on May 15, 2020 for the product Doxycycline. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1276-2020
Failed dissolution specifications
05-15-2020
06-03-2020
14,030 bottles
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.
PD-Rx Pharmaceuticals, 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
11-08-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
