KRS Global Biotechnology Recalls Trimix #22F Due to Labeling Errors
KRS Global Biotechnology is recalling 235 vials of Trimix #22F because the Beyond Use 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 (incorrect or missing lot/exp date) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 235 vials of Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), a prescription medication for intracavernous use. The recall is due to labeling errors where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected product is distributed nationwide in the USA, Bermuda, and New Zealand. The specific lots involved are 05262017@21 with a BUD of 11/22/2017, and 07132017@2 with a BUD of 1/9/2018.
Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the product.
The recalled product
- Product
- Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 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
- 235
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 (2)
- Lot: 05262017@21 BUD: 11/22/2017
- 07132017@2 BUD: 1/9/2018
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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