Recalls / Class II
Class IID-1300-2015
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
- Affected lot / code info
- Lot #: 03172015@39, BUD 07/15/2015
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.
Recalling firm
- Firm
- The Apothecary Shoppe LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6136 E 51st St, N/A, Tulsa, Oklahoma 74135-7704
Distribution
- Quantity
- 10 mL
- Distribution pattern
- Oklahoma
Timeline
- Recall initiated
- 2015-06-26
- FDA classified
- 2015-08-06
- Posted by FDA
- 2015-08-12
- Terminated
- 2017-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1300-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.