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September 2019

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  • Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg

    Monday, September 30, 2019

    Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. To date, Apotex has not received any reports of adverse events related to use of the product.

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  • Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product

    Friday, September 27, 2019

    Sandoz Inc. is voluntarily recalling all quantities and lots within expiryof Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.

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  • Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP

    Friday, September 27, 2019

    Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

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  • Zantac (ranitidine): Safety Information

    Tuesday, September 17, 2019
    ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer)...

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  • Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER

    Wednesday, September 11, 2019
    Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. In the event that impacted...

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  • Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension

    Tuesday, September 10, 2019
    Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification...

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  • The Metrix Company of Dubuque, Iowa is Recalling Specific Lots of the Empty IV Flexible Containers

    Tuesday, September 10, 2019
    The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leaking of the IV bag at the chamber divider rod, which could result in a serious infection...

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