FDA Drug recall D-1300-2015
SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
- FDA Drug
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43 by The Apothecary Shoppe, citing lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1300-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-26 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Apothecary Shoppe |
| Distribution | OK |
Product
SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
Reason
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Identifiers
| code_info | Lot #: 03172015@39, BUD 07/15/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1300-2015%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.