Injectable drug vials recalled for particulate matter contamination
McGuff Compounding Pharmacy Services is recalling Thiamine Hydrochloride and Riboflavin injection vials due to presence of foreign substances in some units.
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: This is an FDA Class II recall of an injectable drug containing foreign particulate matter. No illnesses or injuries have been reported in the source text, making this a theoretical risk-of-harm product without documented clinical harm.
Plain-English summary
McGuff Compounding Pharmacy Services, Inc. is recalling Thiamine Hydrochloride 200 mg/2mL and Riboflavin 2 mg/2mL injection vials, lot 22K1681, due to the presence of particulate matter and foreign substances reported in vials.
The affected product is a sterile, preservative-free injectable medication supplied in 2 mL single-use vials for intramuscular or slow intravenous administration. The recalled lot was distributed nationwide in the United States.
Customers who have received this product should stop using it immediately and contact McGuff Compounding Pharmacy Services or their healthcare provider for guidance on replacement or alternative treatment.
The recalled product
- Product
- Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy…
- Manufacturer
- McGuff Compounding Pharmacy Services, Inc.
- Category
- Drug — Injectable / Compounded
- Affected units
- 11
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)
- Lot: 22K1681
- initial BUD: 12/18/2022
- extended BUD: 1/27/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by McGuff Compounding Pharmacy Services, 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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