SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01
Reported: August 12, 2015 Initiated: June 26, 2015 #D-1301-2015
Product Description
SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01
Reason for Recall
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Details
- Recalling Firm
- The Apothecary Shoppe LLC
- Units Affected
- 163 mL
- Distribution
- Oklahoma
- Location
- Tulsa, OK
Frequently Asked Questions
What product was recalled? ▼
SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01. Recalled by The Apothecary Shoppe LLC. Units affected: 163 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 12, 2015. Severity: Moderate. Recall number: D-1301-2015.
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