CLASS II Drug recall · Reported 3 Dec 2014 · FDA Enforcement Report
Leuprolide 50 mcg/ Micro Lupron Kit, Compounded Rx recalled
Perry Drug is recalling Leuprolide 50 mcg/ Micro Lupron Kit, Compounded Rx, Perry Drug Compounding Pharmacy, distributed in Kansas, Missouri. The recall was initiated on 7 Nov 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0262-2015
- FDA event ID
- 69674
- Recalling firm
- Perry Drug, Overland Park, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2014
- FDA classified
- 24 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 7 Nov 2014 | Recall initiated by company | |
| 24 Nov 2014 | Classified by FDA | +17 days |
| 3 Dec 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
Where it was distributed
Kansas and Missouri
Questions about this recall
Is Leuprolide 50 mcg/ Micro Lupron Kit, Compounded Rx, Perry Drug Compounding Pharmacy recalled?
Yes. Perry Drug recalled Leuprolide 50 mcg/ Micro Lupron Kit, Compounded Rx, Perry Drug Compounding Pharmacy on 7 Nov 2014. The recall is Class II and its status is Terminated. Recall number D-0262-2015.
Why was it recalled?
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.
Which lots are affected?
141007DD, 11/7/14; 141015GG, 11/15/14; 141031II, 12/1/2014; 141031AA, 11/31/14; 141031JJ, 12/1/14;
Where was it sold?
Kansas and Missouri
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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