Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C 25/50/50 vials because the company cannot guarantee the product is sterile.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral product, which poses a significant risk of serious injury.
Plain-English summary
Medaus, Inc. is recalling M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) vials, which contain methionine, inositol, and choline chloride. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is available in 5 mL and 10 mL vials. The specific lot number is 160107-17, with a best-use date of 07/05/16. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable
- 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)
- a) Lot #: 160107-17
- BUD: 07/05/16. b) Lot #: 160107-17
- BUD: 07/05/16.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 88 recalled by Medaus, 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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