Shionogi Recalls Nisoldipine Extended Release Tablets for Failed Dissolution Specifications
Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17 mg, because they failed to meet dissolution specifications. The recall covers products distributed nationwide and in Puerto Rico.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Shionogi Inc. is voluntarily recalling Nisoldipine Extended Release Tablets, 17 mg, in 100-count bottles. The recall is being conducted because the affected lots failed to meet dissolution specifications. The products are manufactured by Aenova France SAS and are available under the brand name Sular (NDC 59630-501-10) and as generic Nisoldipine Extended Release tablets (NDC 66993-473-02).
The recall includes 483 bottles of the Sular brand and 5,631 bottles of the generic brand. The affected lot numbers are 8803472 and 8803473, both with an expiration date of 03/16. These products were distributed nationwide and in Puerto Rico.
The U.S. Food and Drug Administration has classified this recall as Class III, which indicates that the violation of labeling or manufacturing requirements is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- Product
- NISOLDIPINE (NISOLDIPINE)
- Brand
- NISOLDIPINE
- Manufacturer
- Shionogi Inc.
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) 8803472
- Exp 03/16
- b) 8803473
UPCs (1)
- 359630501105
Distribution
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