D-1164-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 26, 2014
- Initiation Date
- January 28, 2014
- Termination Date
- April 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 syringes
Product Description
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***
Reason for Recall
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Distribution Pattern
Product was distributed in Virginia and Maryland.
Code Information
Lot number: 12052013:03 Expiration date: 06/03/2014