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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76789

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 12, 2017
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Meridian Medical Technologies a Pfizer Company

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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.

D-0690-2017
Recall number
D-0690-2017
Initiated
March 12, 2017
Classification
Class I
Status
Ongoing
Quantity
373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Code information

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.

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.

drug · product 2 of 2

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.

D-0691-2017
Recall number
D-0691-2017
Initiated
March 12, 2017
Classification
Class I
Status
Ongoing
Quantity
92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Code information

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 ***

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.