FDA Drug recall D-0737-2023
diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc…
- FDA Drug
- Class II
- terminated
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc… by Central Admixture Pharmacy Services, citing lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0737-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-04-28 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7089-1.
Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Identifiers
| code_info | Lot # 37-884145, 37-884154, Exp 05/03/2023; 37-885931, Exp 05/10/2023; 37-888293, Exp 05/21/2023; 37-889057, 37-889063,…Lot # 37-884145, 37-884154, Exp 05/03/2023; 37-885931, Exp 05/10/2023; 37-888293, Exp 05/21/2023; 37-889057, 37-889063, Exp 05/23/2023; 37-891437, Exp 06/01/2023; 37-893455, Exp 06/11/2023; 37-893788, Exp 06/12/2023; 37-894302, Exp 06/13/2023; 37-894652, Exp 06/14/2023; 37-896817, Exp 06/22/2023; 37-897263, Exp 06/26/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0737-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.