FDAClass IIJune 3, 2020

Doxycycline Hyclate tablets USP recall: Failed Dissolution

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

Why was Doxycycline Hyclate tablets USP recalled?

Failed dissolution specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
PD-Rx Pharmaceuticals, Inc.
Quantity
14,030 bottles
Distribution
USA Nationwide
Recall date
June 3, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls