KRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 898 vials of Sincalide 5 mcg due to incorrect or missing lot and expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves minor labeling errors regarding dates, which aligns with the rubric for moderate severity.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 898 vials of Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only. The recall was initiated because of labeling errors where the Beyond Use Date (BUD) exceeded the expiration date of at least one ingredient used to make the final product.
The affected product is identified by Lot 07052017@2 with a BUD of 1/1/2018. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the affected vials and contact the manufacturer or their supplier for instructions on return or disposal.
The recalled product
- Product
- Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 898
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 (1)
- Lot: 07052017@2 BUD: 1/1/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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