Promise Pharmacy Recalls ICB-Complex Injections Due to Sterility Concerns
Promise Pharmacy is recalling 846 vials of ICB-Complex injection nationwide due to a lack of sterility assurance.
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 involves a lack of sterility assurance in an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
Promise Pharmacy, LLC is recalling 846 vials of ICB-Complex injection. The product is a prescription-only compounded medication containing inositol, choline, various B vitamins, leucine, carnitine, chromium, and lidocaine. The recall is being conducted because of a lack of sterility assurance.
The affected lots are 09262018@1, 10232018@5, and 11012018@3. The products were distributed nationwide in the USA. The recall is classified as FDA Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 846
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)
- Lots: 09262018@1 BUD: 12/25/2018
- 10232018@5 BUD: 1/21/2019
- 11012018@3 BUD: 1/30/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC 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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