Status
Terminated
Drug Enforcement D-0709-2023
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Classification
Class II
Report Date
May 31, 2023
Termination Date
June 22, 2025
Product Information
- Product description
- oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6043-1.
- Product quantity
- 5544 bags
- Reason for recall
- Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
6580 Snowdrift Rd Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0709-2023
- Event ID
- 92253
- Recall initiation date
- April 28, 2023
- Center classification date
- May 19, 2023
- Code info
- Lot # 37-883938, Exp 05/02/2023; 37-884910, 37-884915, Exp 05/07/2023; 37-886041, Exp 05/10/2023; 37-887515, 37-887520, Exp 05/16/2023; 37-888318, Exp 05/21/2023; 37-888847, Exp 05/22/2023; 37-890535, Exp 05/29/2023; 37-890957, Exp 05/30/2023; 37-891566, 37-891568, Exp 06/01/2023; 37-892156, Exp 06/05/2023; 37-893165, 37-893166, Exp 06/08/2023; 37-893994, 37-893995, Exp 06/12/2023; 37-895771, 37-895773, 37-895775, Exp 06/19/2023; 37-896614, Exp 06/21/2023; 37-900377, Exp 07/06/2023
- More code info
- —