Reported Aug 12, 2015 · Terminated
SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,…
The Apothecary Shoppe LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Apothecary Shoppe LLC · 6136 E 51st St · Tulsa, OK · 74135-7704
Is this the product you have?
- SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
- Lot codes and dates
Lot #s: 04282015@9BUD 10/25/201504172015@15BUD 10/14/201504022015@10BUD 9/1/2015
- Amount recalled
- 378 mL
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
This product could cause temporary or reversible health problems — stop using it.
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