Drug product
Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1392-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 mL
- Official record key
drug-enforcement:D-1392-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: lot# 1157, Use by 09/16/14; lot# 2357, use by 06/01/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility