Injectable Vitamin B Vials Recalled for Particulate Matter Contamination
McGuff Compounding Pharmacy recalls 255 vials of thiamine and riboflavin injection nationwide due to foreign substances found in some vials.
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 a risk-of-harm product (injectable with particulate matter contamination). Although classified as FDA Class II, no illnesses or injuries have been reported, placing it at High severity per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
McGuff Compounding Pharmacy Services, Inc. is recalling 255 vials of Thiamine Hydrochloride 3000 mg/30 mL and Riboflavin 30 mg/30 mL injection for intramuscular or slow intravenous use. The product was distributed nationwide. The recall was issued because foreign substances and particulate matter were discovered in some vials at the pharmacy. Affected lot numbers are 22K1661 (beyond-use date extended to 1/27/2023) and 22J2401 (beyond-use date 12/19/2022). Healthcare providers and patients who received vials from these lots should stop using the product immediately. Patients should consult with their healthcare provider if they received this product, and healthcare providers should contact McGuff Compounding Pharmacy Services for guidance on return or disposal.
The recalled product
- Product
- Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc…
- Manufacturer
- McGuff Compounding Pharmacy Services, Inc.
- Category
- Drug — Injectable / Compounded
- Affected units
- 255
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 (5)
- Lot: 22K1661
- initial BUD: 12/18/2022
- extended BUD: 1/27/2023
- 22J2401
- BUD: 12/19/2022.
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.
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