The Recall Desk
HighFDA (Drugs)·D-0266-2023·Announced 2023-02-22

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.

What this means for you

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 Service
Manufacturer
McGuff Compounding Pharmacy Services, Inc.
Category
Drug — Injectable / Compounded
Hazard
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.

See all 2 products in this recall →

Related recalls

Same manufacturer · McGuff Compounding Pharmacy Services, Inc.

See all →

Same hazard · particulate matter

See all →