Recall: Sagent Methylprednisolone Sodium Succinate For Injection, USP 40mg, 125mg, And 1g
On 2018-03-05, the FDA announced that Sagent Pharmaceuticals is conducting a recall on Methylprednisolone Sodium Succinate For Injection, USP 40mg, 125mg, And 1g due to a possible elevated impurity. The recalled products were sold under the brand name(s) Sagent during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 1 drugs recalls due to potential elevated impurity, including homeopathic products, side head regulator tt tablets and more. Additionally, there have been 21 drug and medical device recalls due to other health hazards as well as 76 food recalls.
Company Contact Information:
Name: Sagent Pharmaceuticals
Phone: (866) 625-1618
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g
Brand Name(s): Sagent
Reason for Recall: Out of Specification Impurity Results
Official Recall Date: 2018-03-05
Additional information provided by the FDA.gov:
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots. This impurity has not yet been identified. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.