Urgent ProductRecall Notification (Initiated07-10-2015)
Pharmedix® is requesting the return ofthe following product manufactured by Sun Pharma as follows:
| Level of Recall: | RETAIL |
| Product Name: | Clonidine HCl 0.2mg Tablets |
| Manufacturer: | Sun Pharma |
| PMXNDC# | 494-30, 494-00 |
| PMXLIST# (MNFCT NDC#) | 53489-216-01 & 53489-216-10 |
| Reason for Recall: | Recalled due to Clonidine HCl drug substance lot used in manufacturering of drug products dispensed in the unauthorized rooms by drug substance manufacturer. The analysis performed by contract lab found no contamination in the drug substance lot; the extentofcontaminationwas too little to be detected and is unlikely to cause any adverse effects. |
| Recalled PMX Lot#’s | 14196-015, 14210-020, 14224-015, 14251-011 |
| Recalled Mnfct Lot#’s | 6643901,6677201,6677101 |
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/have been shipped to your clinic. Please examine your inventory to verify if you have product fromthese lots remaining in stock. If so, please discontinue dispensing itand quarantine the product.
Please complete the last column in the box below and fill in the # of unitsremaining in stock. If you do not have any recalled product left,put a zero. Then sign where indicatedand 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. Once this completed formis sent back to Pharmedix® and you do have recalled product to return to Pharmedix®, you will receive pre-approved paperwork to be used when returning the recalled product. Complete the paper as instructed and follow the directions for packing and shipping the recalled product. Pharmedix® will issue a UPS call tag to pick-up the recalled product and thenissue you credit to your account.
If you have any additional questions, call Pharmedix® at 1-800-486-1811, Ext. 12
Sincerely,
Richard J. Mangini, PharmD Pharmedix®
Client Services