RecallRadar

FDA Drug recall D-1301-2015

SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01

On 2015-08-12 the FDA classified a Class II recall of SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01 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

AgencyFDA Drug
Recall numberD-1301-2015
ClassificationClass II
Statusterminated
Initiated2015-06-26
Published2015-08-12
Last updated2026-09-13 11:51 UTC
CompanyThe Apothecary Shoppe
DistributionOK

Product

SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01

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_infoLot #s: 04172015@33, BUD 10/14/2015; 04292015@10, BUD 10/26/2015

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-1301-2015%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.