Status
Terminated
Drug Enforcement D-0952-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 28, 2025
Product Information
- Product description
- glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1
- Product quantity
- 770 Syringes
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
2200 S 43rd Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0952-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-247022, Exp 08/07/2023; 36-239877, Exp 07/13/2023; 36-241448, Exp 07/20/2023; 36-251782, Exp 08/29/2023
- More code info
- —