Class I Recall CLASS I RECALL

Transcription

1 Class I Recall CLASS I RECALL 08/21/2018 Dear Member, On Friday August 17, 2018 Torrent Pharmaceuticals Limited initiated a voluntary recall to the consumer level of Valsartan/Amlodipine/HCTZ. Today we are expanding the number of impacted batches for that product and adding Amlodipine/Valsartan tablets to the ongoing recall. Please see attachment for more information and response form Mutual SKU #s are: , , , , Product Name Description NDC Batch/ Lot Amlodipine/Valsartan/ 10mg/320mg/25mg, HCTZ 10mg/160mg/25mg, mg/160mg/12.5mg, mg/160mg/12.5mg & mg/160mg/25mg See Attached List Amlodipine/Valsartan 5 mg/160 mg mg/160 mg mg/320 mg mg/320 mg With this recall, you are asked to: Check your inventory for the affected product. Immediately discontinue distribution of the product being recalled Notify any patients that you may have further distributed this product to. DO NOT RETURN ANY AFFECTED PRODUCTS TO MUTUAL DRUG Return response form to fax # or via Recall@qualanex.com Contact Nikki Basinger or Brent Slaughter if you have additional questions. Please acknowledge receipt of this Class I Recall and return this letter to NC Mutual Wholesale Drug. You may return by fax to (919) or by to: nbasinger@mutualdrug.com Store Name Customer # Printed Name Signature Date

2 UPDATED:URGENT DRUG RECALL Date August 20, 2018 Product Name Description NDC Batch/Lot Amlodipine/Valsartan/ HCTZ Amlodipine/Valsartan 10mg/320mg/25mg, 10mg/160mg/25mg, 10mg/160mg/12.5mg, 5mg/160mg/12.5mg & 5mg/160mg/25mg 5 mg/160 mg 10 mg/160 mg 10 mg/320 mg 5 mg/320 mg See Attached List Dear Customer, On Friday August 17, 2018 Torrent Pharmaceuticals Limited initiated a voluntary recall to the consumer level of Valsartan/Amlodipine/HCTZ. Today we are expanding the number of impacted batches for that product and adding Amlodipine/Valsartan tablets to the ongoing recall. Our records indicate that you have purchased product from the subject batch/lot. This recall is being conducted with the knowledge of the Food and Drug Administration. This recall is due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Torrent Pharmaceuticals Limited requests that you immediately take the following actions: 1. Immediately examine your inventory, quarantine product subject to the recall and Stop distribution of the lot(s) identified below. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 2. Please complete the enclosed Business Response Form indicating either: a. You have examined your inventory and have none of the recalled product in Stock or, b. Upon examining your inventory you have found the effected recall product which will be quarantined. In the event you have Recall product, please return to Qualanex, LLC., using the Postage Paid Product Return label that will be provided and mail to the following: Qualanex, LLC Harris Road Libertyville, IL Please return the enclosed Business Response Form via fax to or to Recall@qualanex.com. This action applies only to the products and lots addressed in this notification. Only product from these batch/lot will be accepted under the terms of this recall.

3 If you have any medical questions regarding this recall, please contact Torrent Pharma Inc. at (8:00 am 5:00 pm Eastern Time). If you have any general questions regarding the return of this product please contact Qualanex at (8:00 am-5:30 pm Eastern Time). We regret any inconvenience and appreciate your immediate cooperation. Dawn Chitty VP, Strategy and Scientific Affairs NDC Product Description Lot/Batch BBX2D025 Expiration Date BBX2D026 BBX2E001 BBX2E002 BBX2E003 BBX2E004 BBX2E005 NDC , USP 10mg/160mg/25mg, 30 BBX9D004 NDC , USP 10mg/160mg/25mg, 30 BBX9E001, USP 5mg/160mg/12.5mg, 30 BBY1E001 Dec-2019, USP 5mg/160mg/12.5mg, 30 BBY1E003 Mar-2020 NDC , USP 10mg/160mg/12.5mg, 30 BBY2E001 Mar-2020 NDC , USP 5mg/160mg/25mg, 30 BBY4D004 NDC , USP 5mg/160mg/25mg, 30 BBY4E001 BBX2D003 BBX2D004 BBX2D005

4 NDC Product Description Lot/Batch Expiration Date BBX2D006 BBX2D007 BBX2D008 BBX2D015 BBX2D016 BBX2D017 BBX2D018 BBX2D019 BBX2D020 BBX2D021 BBX2D022 BBX2D023 BBX2D024 NDC , USP 10mg/160mg/25mg, 30 BBX9D001 Feb-2019, USP 5mg/160mg/12.5mg, 30 BBY1C002 Sep-2018, USP 5mg/160mg/12.5mg, 30 BBY1E002 Mar-2020 NDC , USP 10mg/160mg/12.5mg, 30 BBY2D001 Feb-2019 NDC , USP 10mg/160mg/12.5mg, 30 BBY2D002 NDC Amlodipine and Valsartan, USP, 30 BV53D004 NDC Amlodipine and Valsartan, USP, 30 BV65D002 NDC Amlodipine and Valsartan, USP, 30 BV77D013

5 NDC Product Description Lot/Batch NDC NDC Amlodipine and Valsartan, USP, 30 Amlodipine and Valsartan, USP, 30 BV84D010 BV84E001 Expiration Date Dec-2019

6 UPDATED AUG 20, 2018: URGENT DRUG RECALL BUSINESS RESPONSE FORM UPDATED INFORMATION IN RED Product Name Description NDC Batch/Lot Amlodipine/Valsartan/ HCTZ Amlodipine/Valsartan 10mg/320mg/25mg, 10mg/160mg/25mg, 10mg/160mg/12.5mg, 5mg/160mg/12.5mg & 5mg/160mg/25mg 5 mg/160 mg 10 mg/160 mg 10 mg/320 mg 5 mg/320 mg BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX9D004, BBX9E001, BBY1E001, BBY1E003, BBY2E001, BBY4D004, BBY4E001, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024 BBX9D001, BBY1C002, BBY1E002, BBY2D001, BBY2D002 BV53D004, BV65D002, BV77D013, BV84D010, BV84E001 Please fill out and either fax to (847) or to Recall@qualanex.com. Quantity Being Returned Full/Sealed Bottles Partial Bottles Tablet Count of Partial Bottles We have examined our inventories and have none of the above recalled product in stock: (initials) Completed by: (Please Print) Name/Title: Company Name: Address: City, State, Zip: DEA Number: Date: Phone: Wholesaler: Wholesaler AccT# DEA Number: Signature: