John W Hollis Inc Recalls Lipotropic Gold Injectable Due to Sterility Concerns
John W Hollis Inc is recalling 80 mL vials of Lipotropic Gold injectable products because they may lack sterility assurance.
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 involves a lack of sterility assurance in injectable products, which poses a significant risk of infection and potential hospitalization.
Plain-English summary
John W Hollis Inc is recalling 80 mL vials of Lipotropic Gold, a compounded aseptically filled injectable product. The recall is due to a lack of assurance of sterility in the products.
The affected product is identified by lot number 2571 with a use-by date of 9/23/14. The product was distributed nationwide. Lipotropic Gold contains levocarnitine, thiamine, riboflavin-5 phosphate, niacinimide, calcium pantothenate, cyanocobalamin, methionine, choline, inositol, and sterile water for injection.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th…
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Compounded Injectable
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: 2571
- use by 9/23/14
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.
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