Key Takeaway

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57 by Perry Drug Inc. was recalled on November 7, 2014. The hazard: Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated wi...

FDA Drug Class II Terminated

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57

Recalled: November 7, 2014 ~5 vials units affected D-0262-2015

Description

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57

Hazard / Reason

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

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

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57

Drugs

Company Information

Perry Drug Inc.

Overland Park, KS, United States

View all 17 recalls by Perry Drug Inc. →

Distribution

Kansas and Missouri

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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.