The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1393-2014·Announced 2014-06-25

John W Hollis Inc Recalls MIC Plus B12 Injectable Due to Sterility Concerns

John W Hollis Inc is recalling MIC Plus B12 injectable vials because the products lack assurance of sterility. Consumers should stop using the affected lots immediately.

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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a structural defect (lack of sterility assurance) in an injectable product is classified as Severe (Score 4).

Plain-English summary

John W Hollis Inc is recalling MIC Plus B12, Adenosine, L-Carnitine injectable vials. The recall is due to a lack of assurance of sterility in the compounded aseptically filled injectable products. The affected product is a 30 mL multi-dose vial containing Methionine, Choline, Inositol, B12, Adenosine, and L-Carnitine, with Benzyl Alcohol as a preservative.

The recall covers Lot 1507 with a use-by date of 5/18/14 and Lot 1863 with a use-by date of 7/20/14. The total quantity involved is 210 mL. The products were distributed nationwide.

Consumers and healthcare providers should stop using the affected products immediately. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203…
Manufacturer
John W Hollis 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 (4)

  • Lot 1507
  • Use by 5/18/14
  • Lot 1863
  • Use by 7/20/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by John W Hollis 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 19 products in this recall →

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