Lipo-Mino-Mix Injectable Compounded Drug Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix injectable vitamins nationwide due to manufacturing failure to ensure product sterility. No illnesses have been reported.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Lack of sterility assurance in injectable products constitutes a high-risk scenario representing a risk-of-harm product where serious infection could occur. No illness or contamination has been confirmed, but the potential hazard severity warrants High classification per the rubric.
Plain-English summary
Olympia Compounding Pharmacy is recalling Lipo-Mino-Mix, an injectable compounded product containing vitamins and amino acids (Pyridoxine HCL B6, Thiamine HCL B1, Riboflavin B2, Methionine, Inositol, and Choline Chloride). The product is supplied in 10 mL and 30 mL multi-dose vials and is available only by prescription.
The recall is issued because the manufacturer cannot assure that the product meets sterility requirements. A total of 3,762 vials have been distributed nationwide throughout the United States, Puerto Rico, and the U.S. Virgin Islands. Affected lots are A24103 (with expiration date 7/3/2022) and B41B01-22 (with expiration date 8/1/2022).
Lack of sterility assurance in injectable products poses a potential risk for microbial contamination. No illnesses or adverse events have been reported to date. Healthcare providers and patients should discontinue use of affected vials immediately and contact Olympia Compounding Pharmacy or consult with their healthcare provider regarding replacement therapy.
The recalled product
- Product
- Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only…
- Category
- Drug — Compounded Injectable
- Affected units
- 3,762
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)
- Lots: A24103 BUD: 7/3/2022
- B41B01-22 BUD: 8/1/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy 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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