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SafetyAlerts
April 9, 2003

Lee Pharmacy Has Recalled Acetate Injection

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Methylprednisolone Acetate Injection, 40mg/mL P.F.,
Preservative Free, Single Dose Vial, sold in 1ml, 2ml,
5ml, or 10ml vials. Recall # D-197-3;
b) Methylprednisolone Acetate Injection, 80mg/mL,
Preservative Free, Single Use Vial, sold in 1ml, 2ml,
5ml, or 10ml vials. Recall # D-198-3.

CODE
a) 28022002:03 02012002:56 24012002:95 05022002:11
21022002:91 04042002:29 01052002:01 07052002:06
09052002:33 14082002:59 19092002:45;
b) 4667:47A, 4667:47B, 4667:47C : 02012002:30 22012002:71
29012002:38 08022002:79 13022002:59 16022002:12
22022002:89 28022002:09 12032002:39 19032002:09
04042002:32 30042002:35 07052002:20 09052002:75
14052002:70 03062002:58 20062002:32 06082002:46
22082002:37 03092002:79 23092002:29 4651:14
4750:65 4775:88.

RECALLING FIRM/MANUFACTURER
Lee Pharmacy, Inc., Fort Smith, AR, by letters dated December 24, 2002 and December 30, 2002. Firm initiated recall is ongoing.

REASON
a) Microbial contamination;
b) Fungal contamination (Cladosporium).

VOLUME OF PRODUCT IN COMMERCE
Unknown

DISTRIBUTION
Nationwide.

 

 
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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.