FDA-Drug2014-03-26Class II

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***

RX South LLC DBA RX3 Pharmacy
Hazard

Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

Sold states
Product was distributed in Virginia and Maryland.
Affected count
250 syringes
Manufactured in
12230 Iron Bridge Rd, Ste. C, Chester, VA, United States
Products
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***

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1164-2014

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