Pharmedix® is requesting the return of the following product manufactured by Nephron as follows:
|
Level of Recall: |
RETAIL |
|
Product Name: |
Albuterol Inhalation Solution, 0.083% |
|
Manufacturer: |
Nephron Pharmaceuticals Corporation |
|
NDC Code# |
0487-9501-25 |
|
PMX Order Code |
PB00003 |
|
Mnfct Lot #s |
A3A33B |
|
PMX Lot #’s |
13283-031 |
|
Reason for Recall |
Recalled as a precautionary measure due to results from internal monitoring of aseptic processes. |
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. You DO NOT need to contact any clients to whom the product was dispensed.
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. 12 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, place a zero in the number of units remaining column. 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