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Medium RiskFDA Vet
Pets & Animals/Pet Medications

KRS Global Biotechnology, Inc: Various Compounded Veterinary Medications Recalled for Incorrect Expiration Dates

Agency Publication Date: March 10, 2018
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Summary

KRS Global Biotechnology, Inc. is recalling 24,485 units of various compounded veterinary medications, including Anastrozole, Piroxicam, Cyclophosphamide, Lomustine, and Melphalan capsules. These medications were recalled because the Beyond Use Date (BUD) or expiration date printed on the labels exceeds the expiration date of at least one of the ingredients used to make the final product. This means the medication may lose its effectiveness or safety before the date listed on the bottle. These products were distributed nationwide in various dosage strengths.

Risk

The medications may be used past their actual stable shelf life because the labels provide an inaccurate expiration date. This could result in the animal receiving a sub-potent or degraded medication that does not provide the intended therapeutic benefit for conditions like inflammation, cancer, or hormonal issues.

What You Should Do

  1. Check your medication bottles for the following compounded products from KRS Global Biotechnology: Anastrozole, Piroxicam, Cyclophosphamide, Lomustine, or Melphalan.
  2. Identify if your lot is affected by checking the 'BUD' (Beyond Use Date) and Lot number on the label against the specific list of affected lots, such as Anastrozole Lot 07212017@37 (BUD 07/16/2018) or Piroxicam 1 mg Lot 01242017@11 (BUD 01/19/2018).
  3. If your product is part of the recall, contact your veterinarian or healthcare provider immediately to discuss alternative treatment options for your animal.
  4. Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
  5. Contact KRS Global Biotechnology, Inc. at 888-502-2050 if you have any specific questions regarding this recall or the affected products.
  6. For additional information or to report adverse events, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

💰Full Refund

Refund for unused product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Anastrozole 0.25 mg capsule (90 capsules)
Model:
V-0032-2018
Lot Numbers:
07212017@37 (BUD: 07/16/2018)
08162017@42 (BUD: 08/11/2018)
Date Ranges: 07/16/2018, 0811/2018
Product: Piroxicam 1 mg capsule (1895 capsules)
Model:
V-0033-2018
Lot Numbers:
01242017@11 (BUD: 01/19/2018)
02082017@14 (BUD: 02/03/2018)
Date Ranges: 01/19/2018, 02/03/2018
Product: Piroxicam 3 mg capsule (3820 capsules)
Model:
V-0034-2018
Lot Numbers:
01172017@29 (BUD: 01/12/2018)
02142017@28 (BUD: 02/09/2018)
12072016@28 (BUD: 12/02/2017)
Date Ranges: 01/12/2018, 02/09/2018, 12/02/2017
Product: Piroxicam 5 mg capsule (2700 capsules)
Model:
V-0035-2018
Lot Numbers:
01042017@49 (BUD: 12/30/2017)
02212017@28 (BUD: 2/16/2018)
12162016@27 (BUD: 12/11/2017)
Date Ranges: 12/30/2017, 2/16/2018, 12/11/2017
Product: Piroxicam 9 mg capsule (290 capsules)
Model:
V-0036-2018
Lot Numbers:
10242017@37 (BUD: 4/22/2018)
Date Ranges: 4/22/2018
Product: Cyclophosphamide 5 mg capsule (1500 capsules)
Model:
V-0037-2018
Lot Numbers:
02032017@28 (BUD: 1/29/2018)
03032017@25 (BUD: 2/26/2018)
11062017@35 (BUD: 11/1/2018)
Date Ranges: 1/29/2018, 2/26/2018, 11/1/2018
Product: Cyclophosphamide 10 mg capsule (1500 capsules)
Model:
V-0038-2018
Lot Numbers:
01242017@11 (BUD: 1/19/2018)
02082017@14 (BUD: 2/3/2018)
Date Ranges: 1/19/2018, 2/3/2018
Product: Cyclophosphamide 15 mg capsule (600 capsules)
Model:
V-0039-2018
Lot Numbers:
02142017@21 (BUD: 2/9/2018)
Date Ranges: 2/9/2018
Product: Cyclophosphamide 25 mg capsule (1500 capsules)
Model:
V-0040-2018
Lot Numbers:
01262017@19 (BUD: 1/21/2018)
04272017@39 (BUD: 4/22/2018)
Date Ranges: 1/21/2018, 4/22/2018
Product: Cyclophosphamide 50 mg capsule (3000 capsules)
Model:
V-0041-2018
Lot Numbers:
01132017@14 (BUD: 1/8/2018)
02022017@13 (BUD: 1/28/2018)
03172017@23 (BUD: 3/12/2018)
Date Ranges: 1/8/2018, 1/28/2018, 3/12/2018
Product: Lomustine 2 mg capsule (90 capsules)
Model:
V-0042-2018
Lot Numbers:
09142017@23 (BUD: 9/14/2018)
Date Ranges: 9/14/2018
Product: Lomustine 2.5 mg capsule (600 capsules)
Model:
V-0043-2018
Lot Numbers:
01162017@27 (BUD: 1/16/2018)
07142017@29 (BUD: 7/14/2018)
Date Ranges: 1/16/2018, 7/14/2018
Product: Lomustine 5 mg capsule (1800 capsules)
Model:
V-0044-2018
Lot Numbers:
02202017@28 (BUD: 2/20/2018)
06152017@16 (BUD: 6/15/2018)
07252017@28 (BUD: 7/25/2018)
09192017@35 (BUD: 9/19/2018)
Date Ranges: 2/20/2018, 6/15/2018, 7/25/2018, 9/19/2018
Product: Lomustine 7.5 mg capsule (100 capsules)
Model:
V-0045-2018
Lot Numbers:
10122017@16 (BUD: 4/10/2018)
Date Ranges: 4/10/2018
Product: Lomustine 10 mg capsule (1500 capsules)
Model:
V-0046-2018
Lot Numbers:
01272017@7 (BUD: 1/27/2018)
08162017@17 (BUD: 8/16/2018)
Date Ranges: 1/27/2018, 8/16/2018
Product: Lomustine 15 mg capsule (900 capsules)
Model:
V-0047-2018
Lot Numbers:
01162017@26 (BUD: 1/16/2018)
10092017@35 (BUD: 4/7/2018)
Date Ranges: 1/16/2018, 4/7/2018
Product: Lomustine 20 mg capsule (300 capsules)
Model:
V-0048-2018
Lot Numbers:
08022017@31 (BUD: 8/2/2018)
Date Ranges: 8/2/2018
Product: Lomustine 25 mg capsule (300 capsules)
Model:
V-0049-2018
Lot Numbers:
04272017@21 (BUD: 4/27/2018)
Date Ranges: 4/27/2018
Product: Lomustine 30 mg capsule (100 capsules)
Model:
V-0050-2018
Lot Numbers:
05082017@30 (BUD: 5/8/2018)
Date Ranges: 5/8/2018
Product: Lomustine 40 mg capsule (300 capsules)
Model:
V-0051-2018
Lot Numbers:
08022017@32 (BUD: 8/2/2018)
Date Ranges: 8/2/2018
Product: Lomustine 50 mg capsule (100 capsules)
Model:
V-0052-2018
Lot Numbers:
12082016@16 (BUD: 12/8/2017)
Date Ranges: 12/8/2017
Product: Lomustine 60 mg capsule (100 capsules)
Model:
V-0053-2018
Lot Numbers:
05082017@31 (BUD: 5/8/2018)
Date Ranges: 5/8/2018
Product: Melphalan 2 mg capsule (1200 capsules)
Model:
V-0054-2018
Lot Numbers:
12152016@35 (BUD: 12/15/2017)
12222016@28 (BUD: 12/22/2017)
Date Ranges: 12/15/2017, 12/22/2017
Product: Melphalan 2.5 mg capsule (200 capsules)
Model:
V-0055-2018
Lot Numbers:
01232017@41 (BUD: 1/23/2018)
12142016@42 (BUD: 12/14/2017)
Date Ranges: 1/23/2018, 12/14/2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78598
Status: Resolved
Manufacturer: KRS Global Biotechnology, Inc
Sold By: KRS Global Biotechnology, Inc
Manufactured In: United States
Units Affected: 24 products (90 capsules; 1895 capsules; 3820 capsules; 2700 capsules; 290 capsules; 1500 capsules; 1500 capsules; 600 capsules; 1500 capsules; 3000 capsules; 90 capsules; 600 capsules; 1800 capsules; 100 capsules; 1500 capsules; 900 capsules; 300 capsules; 300 capsules; 100 capsules; 300 capsules; 100 capsules; 100 capsules; 1200 capsules; 200 capsules)
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response