The Recall Desk
SevereFDA (Drugs)·D-1252-2014·Announced 2014-04-30

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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:

Related recalls

Same hazard · non sterility

See all →