Glycopyrrolate Injectable Recalled for Bacillus thuringiensis Contamination
Brookfield Prescription Center Inc. is recalling one lot of Glycopyrrolate solution for injection due to Bacillus thuringiensis contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Brookfield Prescription Center Inc. is recalling one lot of Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials. The recall is due to non-sterility, as the product was found to be contaminated with Bacillus thuringiensis.
The affected product is identified by Lot # 10292013@15 with a Beyond Use Date of 11/28/2013. The product was distributed in Wisconsin (WI) and is intended for use by licensed professionals only, not for resale.
Consumers and healthcare providers should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.
- Manufacturer
- Brookfield Prescription Center Inc
- Category
- Drug — Injectable
- Affected units
- 25
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)
- Lot #: 10292013@15
- Beyond Use Date: 11/28/2013
Distribution
Distributed in 1 state:
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