Pharmedix® is requesting the return of the following product manufactured by Sanofi-Pasteur as follows:
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Level of Recall: |
RETAIL |
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Product Name: |
Typhim IV Prefilled Syringe |
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Manufacturer: |
Sanofi Pasteur |
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NDC Code # |
49281-790-51 |
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PMX Order Code |
PI00364 |
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Mnfct Lot #s |
E1287-1, E1288-1, G0481-1, G0507-1, G0508-1 |
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PMX Lot #’s |
11019-006, 11105-004, 11117-028, 11133-018, 11140-018, 11201-004, 11314-025, 11335-004, 11349-014, 12025-031, 12054-015, 12109-045, 12125-039, 12130-035, 12138-001, 12193-018, 12228-018 |
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Reason for Recall |
These lots are at risk for lower antigen content-see attached letter from Sanofi Pasteur |
This voluntary recall is extended to the RETAIL level and is being made with the knowledge of the Food and Drug Administration (FDA). This recall is only to your CLINIC LEVEL. Regarding patients who have vaccinated, see attached letter from Sanofi Pasteur.
Our records show that product with the referenced Lot #s has been shipped to your clinic. Please examine your inventory to verify if you have product from these lots remaining in stock. If so, please discontinue dispensing it, quarantine the product, and promptly call Pharmedix® at 1-800-486-1811, Ext. 14 to obtain the approved paperwork to return all concerned product to us for credit to your account.
Please complete the last column in the box below. If you do not have any recalled product left, put a zero. Then sign where indicated and fax this form back to Pharmedix® at 1-800-783-2038 even if you do not have any product from the indicated Lot #(s) remaining in stock
Sincerely,
Richard J Mangini
Richard J. Mangini, PharmD
Client Services