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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 16, 1999

Astra Pharmaceuticals Recalls Astra 4% Citanest Forte with Epinephrine

Westborough, MA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Astra Pharmaceuticals is recalling Astra 4% Citanest Forte with Epinephrine because of Epinephrine subpotency (stability).

PRODUCT
Astra 4% Citanest Forte with Epinephrine 1:200,000 (Prilocaine and Epinephrine Injection, USP), in 1.8 mL cartons, indicated for the production of local anesthesia in dentistry. NDC #0186-0540-14.

Recall #D-255-9.

CODE 
Lot No.- Expiration Date
0540801072 Jul-99
0540801075 Jul-99
0540802017 Aug-99
0540803036 Sep-99
0540803044 Sep-99
0540803053 Sep-99
0540803072 Sep-99
0540803090 Sep-99
0540804018 Oct-99
0540804023 Oct-99
0540804037 Oct-99
0540804049 Oct-99
0540804054 Oct-99
0540804103 Oct-99
0540804107 Oct-99
0540805001 Nov-99

MANUFACTURER
Astra Pharmaceuticals, L.P., Westborough, Massachusetts.

RECALLED BY
Manufacturer, by letter on May 28, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
56,252 units were distributed

 

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.