Drug product
Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
D-66241-001
Product summary
- Event
- Event 66241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3540 mL
- Official record key
drug-enforcement:D-66241-001
Official wording
Reason: Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Code information: Lot 05022013@20, Exp 10/29/13
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility