The Recall Desk
SevereFDA (Drugs)·D-0262-2015·Announced 2014-12-03

Perry Drug Recalls Leuprolide Micro Lupron Kits Due to Sterility Concerns

Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in a sterile compounded drug, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits, 5Ml, Compounded Rx, manufactured by Perry Drug Compounding Pharmacy in Overland Park, KS. The recall affects all lots of sterile products compounded by the pharmacy that are within their expiration date. The product was distributed in Kansas and Missouri.

The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The specific lot codes associated with the recall include 141007DD, 141015GG, 141031II, 141031AA, and 141031JJ.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 141007DD
  • 11/7/14
  • 141015GG
  • 11/15/14
  • 141031II
  • 12/1/2014
  • 141031AA
  • 11/31/14
  • 141031JJ
  • 12/1/14

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 17 recalled by Perry Drug Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →