Why it was recalled
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 10292013@15, Beyond Use Date: 11/28/2013
Where it was sold
WI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1252-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 13, 2013
- FDA report date
- Apr 30, 2014
- Quantity
- 25 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brookfield Prescription Center Inc
Original FDA data
Every field from FDA enforcement report D-1252-2014, exactly as published.
Show all FDA fields
- City
- Brookfield
- State
- WI
- Status
- Terminated
- Country
- United States
- Event ID
- 67026
- Address
- 19035 W. Capitol Dr
- Address (line 2)
- Suite 105
- Code information
- Lot #: 10292013@15, Beyond Use Date: 11/28/2013
- Postal code
- 53045
- Report date
- Apr 30, 2014
- Product type
- Drugs
- Recall number
- D-1252-2014
- Classification
- Class I
- Recalling firm
- Brookfield Prescription Center Inc
- Product quantity
- 25 Vials
- Termination date
- May 30, 2014
- Reason for recall
- Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- WI
- Recall initiation date
- Nov 13, 2013
- Initial firm notification
- Telephone
- Center classification date
- Apr 21, 2014