Drug product
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***
D-1164-2014
Product summary
- Event
- Event 67432
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 syringes
- Official record key
drug-enforcement:D-1164-2014
Official wording
Reason: Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Code information: Lot number: 12052013:03 Expiration date: 06/03/2014
Distribution pattern: Product was distributed in Virginia and Maryland.
Derived failure modes
-
Unknown
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping