Multi-event August 2020 FDA Recall Drug by Eosera, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Eosera, Inc. on August 4, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1500-2020 TERMINATED D-1498-2020 TERMINATED D-1501-2020 TERMINATED D-1499-2020 TERMINATED

Recall Number: D-1500-2020

Reason for Recall
cGMP Deviations.
Initiated
08-04-2020
Reported
08-19-2020
Quantity
43,424 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86171
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eosera, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2021
Product Description About Product Description
Full technical description of the product.
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125

Batch or Lot Expiration Information

Lot# : F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20

Recall Number: D-1498-2020

Reason for Recall
cGMP Deviations.
Initiated
08-04-2020
Reported
08-19-2020
Quantity
45,673 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86171
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eosera, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2021
Product Description About Product Description
Full technical description of the product.
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8

Batch or Lot Expiration Information

Lot# Lots: P203093 Exp. DEC 21; P203026 Exp. JUN 21; P193084, P193044, Exp. APR 21; P193073, P193072, P193071, P193070 Exp. FEB 21; P192050 Exp. MAY 21; P193042 Exp. MAR 21; P193013 Exp. JAN 21; P193012 Exp. DEC 20

Recall Number: D-1501-2020

Reason for Recall
cGMP Deviations.
Initiated
08-04-2020
Reported
08-19-2020
Quantity
15229 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86171
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eosera, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2021
Product Description About Product Description
Full technical description of the product.
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5

Batch or Lot Expiration Information

Lot# : TP203073 Exp. SEP 21; TP203055 Exp. OCT 21; TP203012, TP203009, TP203006 Exp. JUN 21

Recall Number: D-1499-2020

Reason for Recall
cGMP Deviations.
Initiated
08-04-2020
Reported
08-19-2020
Quantity
125,874 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86171
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eosera, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2021
Product Description About Product Description
Full technical description of the product.
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2

Batch or Lot Expiration Information

Lot# : P203076, P203075 Exp. NOV 21; P203061, P203057 Exp. AUG 21; P203047, P203044, P203040, JUL 21; P203033, P203030, P203016, P203015, P203002, P203001, P193053 Exp. JUN 21; P203024, P193097 Exp. MAY 21; P203017 Exp. JUL 20; P193091, P193089, P193088, P193087 Exp. APR 21; P193068, P193067 Exp. FEB 21; P193064, P193063, P193062, P193059, P193014 Exp. JAN 21; P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001, Exp. DEC 20; P183018, P183017 Exp. SEP 20