The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1206-2016·Announced 2016-07-20

Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

Medaus, Inc. is recalling Lipo-Injection vials containing methyl B12 and other vitamins due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Medaus, Inc. is recalling Lipo-Injection vials containing methyl B12, ascorbic acid, and other vitamins. The recall was initiated because of a lack of assurance of sterility in the product.

The affected product is available in 5 mL and 10 mL vials. The specific lot number is 160208-41, with a best-use date of 07/31/16. The total quantity involved is 2000 mL in vials.

The product was distributed nationwide in the U.S., as well as in Japan and New Zealand. Consumers should stop using the product and contact Medaus, Inc. for further instructions.

The recalled product

Product
LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/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 #: 160208-41
  • BUD: 07/31/16. b) Lot #: 160208-41
  • BUD: 07/31/16.

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.

See all 88 products in this recall →

Related recalls

Same manufacturer · Medaus, Inc.

See all →

Same hazard · sterility

See all →

Similar recalls