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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 24, 1998

PRODUCT
a) Epi Pen, Auto Injector (Epinephrine Injection 1:1000), 0.3mL, 0.3 mg, 1 EpiPen per box, 12 units per carton or tray, RX, labeled under three different responsible firm names:
(1) Dey Pharma label (NDC #49502-500-01)

(2) Center label (NDC #0268-0301-01)and

(3) Center label (NDC #0268-0301-01)

b) EpiPen Jr., Auto-Injector 0.15 mg (Epinephrine Injection 1:2000), 0.3mL, 0.15 mg, for allergic emergencies (anaphylaxis), RX, labeled under three different responsible firm names:
(1) Dey Pharma label - NDC #49502-501-01;

(2) Center label - NDC #0268-0302-01; and

(3) Center label - NDC #0268-0302-01. Recall #D-150/151-8.

CODE
Lot numbers: 7SX208, 7SX209, 7SX216, 7SX217, 7SX194, 7RX204, 7RX223, 7SR247, 7SR265, 7SR286, 7SR292, 7SR293, 7SR317, 7SR318, 7SR321, 7SR342, 7SR355, 7SR356, 7SR358, 7SR370, 7SR371, 7SR378, 7JR242, 7JR243, 7JR289, 7JR290, 7JR323, 7JR361, 7JR362, 7JR374, 7JR375, 8SR004, 8SS077, 8SS078, 7C6214, 7C6279, 7C8277, 7C8381, 7F7221, 7F7262, 7F7380, 7C5238, 7C5376, 7F8391, 7F8220, 7F8263, 7CA382.

MANUFACTURER
Meridian Medical Technologies, Inc., St. Louis, Missouri.

RECALLED BY
Manufacturer, by press release on May 8, 1998, and by letter dated May 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 1,000,000 auto-injectors were distributed.

REASON
Subpotency

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.