The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1398-2014·Announced 2014-06-25

John W Hollis Inc Recalls B-Complex/Adenosine Injectable Solution for Sterility Concerns

John W Hollis Inc is recalling B-Complex/Adenosine Injectable Solution due to a lack of sterility assurance in the compounded aseptically filled products.

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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.

Plain-English summary

John W Hollis Inc is recalling B-Complex/Adenosine Injectable Solution, a compounded aseptically filled injectable product. The recall is being conducted because of a lack of sterility assurance in the affected products.

The specific product involved is a 30 mL solution containing Adenosine-5-Monophosphate, Choline Chloride, Cyanocobalamin, Inositol, Methionine, Levocarnitine, Chromic Chloride, Lidocaine HCl, and Pyrodoxine HCl. The recall covers Lot # 2095 with a use-by date of 8/17/14. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th…
Manufacturer
John W Hollis Inc
Category
Drug — Compounded 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 (2)

  • Lot # 2095
  • Use by 8/17/14

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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