Drug Enforcement D-0734-2023

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Status

Terminated

Classification

Class II

Report Date

May 31, 2023

Termination Date

June 22, 2025

Product Information

Product description
NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
Product quantity
6341 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
E-Mail
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-0734-2023
Event ID
92253
Recall initiation date
April 28, 2023
Center classification date
May 19, 2023
Code info
Lot # 37-882998, 37-883005, 37-883145, Exp 04/28/2023; 37-883144, 37-883220, 37-883221, 37-883222, Exp 04/30/2023; 37-883925, Exp 05/02/2023; 37-884180, 37-884181, Exp 05/03/2023; 37-884505, 37-884506, 37-884507, 37-884508, 37-884509, Exp 05/04/2023; 37-884834, 37-884869, 37-884870, Exp 05/07/2023; 37-886058, Exp 05/10/2023; 37-886536, 37-886537, Exp 05/14/2023; 37-887062, 37-887389, Exp 05/15/2023; 37-887784, 37-887787, Exp 05/17/2023; 37-888029, 37-888048, Exp 05/18/2023; 37-888261, 37-888263, 37-888269, 37-888282, 37-888292, 37-888294, 37-888301, 37-888302, Exp 05/21/2023; 37-890058, 37-890064, 37-890074, 37-890076, Exp 05/28/2023; 37-891747, 37-891748, 37-891750, 37-891751, 37-891753, Exp 06/04/2023; 37-893530, 37-893531, 37-893532, Exp 06/11/2023; 37-894760, 37-894761, Exp 06/14/2023; 37-894988, 37-894990, Exp 06/15/2023; 37-896260, Exp 06/20/2023; 37-896621, Exp 06/21/2023; 37-898518, 37-898519, Exp 06/29/2023; 37-898789, 37-898790, 37-898791, 37-898792, 37-898793, Exp 07/02/2023; 37-899718, Exp 07/04/2023; 37-900591, 37-900596, Exp 07/09/2023; 37-901149, Exp 07/10/2023
More code info
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