Epipen Jr Injection
FDA Recall NDC 49502-501

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 5 recorded enforcement report(s) associated with Epipen Jr (NDC 49502-501). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Viatris Specialty Llc. The reported reason for this action was: "cGMP deviations: Temperature abuse"

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

D-1012-2022TERMINATEDD-0993-2022TERMINATEDD-0528-2021TERMINATEDD-0691-2017ONGOINGD-0690-2017ONGOING

April 2022 Class II Recall: cGMP deviations

Recall Number
D-1012-2022
Class II Terminated
Reason for Recall
cGMP deviations: Temperature abuse
Initiated
Apr 13, 2022
Reported
Jun 15, 2022
Quantity
4 cartons/2 auto injectors each

Recall Profile & Regulatory Data

Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
49502-500-01Product
49502-500-02Product
49502-500-92Product
49502-501-01Product
49502-501-02Product
49502-501-92Product

April 2022 Class II Recall: cGMP deviations

Recall Number
D-0993-2022
Class II Terminated
Reason for Recall
cGMP deviations: Temperature abuse
Initiated
Apr 13, 2022
Reported
Jun 15, 2022
Quantity
5 cartons

Recall Profile & Regulatory Data

Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.
Affected Packages Involved in this Recall
49502-500-01Product
49502-500-02Product
49502-500-92Product
49502-501-01Product
49502-501-02Product
49502-501-92Product

March 2021 Class II Recall: CGMP Deviations

Recall Number
D-0528-2021
Class II Terminated
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
Mar 15, 2021
Reported
Jun 02, 2021
Quantity
620 injector

Recall Profile & Regulatory Data

Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01
Batch or Lot Expiration Information
Lot# 0FM544
Affected Packages Involved in this Recall
49502-500-01Product
49502-500-02Product
49502-500-92Product
49502-501-01Product
49502-501-02Product
49502-501-92Product

March 2017 Class I Recall: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Recall Number
D-0691-2017
Class I Ongoing
Reason for Recall
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Initiated
Mar 12, 2017
Reported
May 10, 2017
Quantity
92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)

Recall Profile & Regulatory Data

Event ID
76789
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Meridian Medical Technologies a Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
Product Description
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
Batch or Lot Expiration Information
Lot# US lot 5GN767, expiration April 2017; lot 5GN773, expiration April 2017; lot 6GN215, expiration Sep 2017: INTERNATIONAL lot 5GR765, expiration March 2017; lot 5GK771, expiration April 2017; lot 5ED824, expiration April 2017; and lot 6ED117, expiration ***
Affected Packages Involved in this Recall
49502-500-01Product
49502-500-02Product
49502-500-92Product
49502-501-01Product
49502-501-02Product
49502-501-92Product

March 2017 Class I Recall: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Recall Number
D-0690-2017
Class I Ongoing
Reason for Recall
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Initiated
Mar 12, 2017
Reported
May 10, 2017
Quantity
373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)

Recall Profile & Regulatory Data

Event ID
76789
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Meridian Medical Technologies a Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
Product Description
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
Batch or Lot Expiration Information
Lot# US: lot 5GM631, exp. April 2017; lot 5GM640, exp. May 2017; lot 6GM072, exp. Sep 2017; lot 6GM082, exp. Sep 2017; lot 6GM088, exp. Oct 2017; lot 6GM087, exp. Oct 2017; lot 6GM198, exp. Oct 2017; lot 6GM081, exp. Sep 2017; lot 6GM091, exp. Oct 2017; lot 6GM199, exp. Oct 2017: INTERNATIONAL: lot 5FA665, exp. April 2017; lot 5GU763, exp. May 2017; lot 6FA293, exp. Oct 2017; lot 6FA292, exp. Oct 2017; lot 6GH294, exp. Oct 2017.
Affected Packages Involved in this Recall
49502-500-01Product
49502-500-02Product
49502-500-92Product
49502-501-01Product
49502-501-02Product
49502-501-92Product

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.