Key Takeaway

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/1 by RX South LLC DBA RX3 Pharmacy was recalled on January 28, 2014. The hazard: Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

FDA Drug Class II Terminated

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/1

Recalled: January 28, 2014 ~250 syringes units affected D-1164-2014

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***

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Drugs

Distribution

Product was distributed in Virginia and Maryland.

Related Recalls

FDA Drug Class II

Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx

January 22, 2013

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.