KRS Global Biotechnology Recalls Trimix #23F Due to Incorrect Expiration Date
KRS Global Biotechnology is recalling 94 vials of Trimix #23F because the product's expiration date exceeds the expiration date of at least one ingredient.
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 a labeling error regarding expiration dates, which fits the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 94 vials of Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), a prescription medication for intracavernous use. The recall is due to a labeling error where the Beyond Use Date (BUD) of the final product exceeds the expiration date of at least one ingredient used to make it.
The affected product is identified by Lot 06142017@6 with a BUD of 12/11/2017. The recall covers distribution in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Prescription Injectable
- Hazard
- Affected units
- 94
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: 06142017@6 BUD: 12/11/2017
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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