FDA Drug recall D-1052-2023
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935…
- FDA Drug
- Class II
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935… by Central Admixture Pharmacy Services, citing lack of assurance of sterility: Lack of validation data for sanitization cycles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1052-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-17 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
Reason
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Identifiers
| code_info | Lot: 17-270599, 17-270600, Exp. 7/17/2023; 17-270785, Exp. 7/19/2023; 17-270969, Exp. 7/23/2023; 17-271116, 17-271135,…Lot: 17-270599, 17-270600, Exp. 7/17/2023; 17-270785, Exp. 7/19/2023; 17-270969, Exp. 7/23/2023; 17-271116, 17-271135, Exp. 7/25/2023; 17-271242, Exp. 7/26/2023; 17-271502, Exp. 7/31/2023; 17-271561, 17-271589, Exp. 8/1/2023; 17-271672, Exp. 8/2/2023; 17-271837, Exp. 8/6/2023; 17-272291, Exp. 8/14/2023; 17-272363, 17-272364, Exp. 8/15/2023; 17-272453, Exp. 8/16/2023; 17-272607, Exp. 8/20/2023; 17-272706, Exp. 8/21/2023; 17-273148, Exp. 8/29/2023; 17-273421, Exp. 9/3/2023; 17-273698, 17-273700, Exp. 9/6/2023; 17-273966, Exp. 9/11/2023. |
|---|
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-1052-2023%22
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