Wedgewood Village Pharmacy, Inc.: Digoxin Veterinary Medications Recalled for Low Potency

Agency Publication Date: July 2, 2013

Summary

Wedgewood Village Pharmacy, Inc. is recalling various formulations of Digoxin, a heart medication for animals, including elixirs, capsules, and oral suspensions. The recall was initiated because testing showed the medication contains less of the active ingredient, digoxin, than stated on the label. When a medication is less potent than intended, it may fail to treat the underlying heart condition effectively, which can lead to a worsening of the animal's health.

Risk

Low potency means the animal is receiving a sub-therapeutic dose of medication required to manage heart failure or rhythm issues. This lack of effectiveness can cause the animal's heart condition to deteriorate, potentially leading to increased heart rate, lethargy, or congestive heart failure.

What You Should Do

Check your pet's medication bottle for the following specific item codes: DIGOXI-SOL502VC, DIGOXISOL0005VC, DIGOXI-SOL501VC, DIGOXI-SOL003VC, DIGOXI-SOL0003VC, DIGOXI-CAP505VC, DIGOXI-SUS509VC, DIGOXI-SUS506VC, DIGOXI-SUS502VC, DIGOXISUS0006VC, DIGOXI-SUS503VC, DIGOXISUS0011VC, DIGOXI-SUS508VC, or DIGOXISUS0030VC.
Verify if your lot number is affected: for elixirs look for 20121002@228, 20121009@233, 20121207@062, 20130107@298, 20130110@052, 20130306@086, 20121101@195, 20130108@042, or 20130220@138; for capsules look for 20121023@117 or 20121106@197; for suspensions look for 201211022@246, 20121025@103, 20121022@296, 20121120@307, 20121207@229, 20121002@037, 20121127@313, 20130103@232, 20130130@060, 20130207@032, 20130304@337, 20130313@012, 20121003@015, or 20130219@021.
Contact your veterinarian or pharmacist immediately to discuss your pet's treatment and to obtain a replacement medication that meets potency standards.
Return any unused portion of the recalled medication to the pharmacy for a refund and contact Wedgewood Village Pharmacy at 856-467-2222 for further instructions.
Monitor your pet closely for any signs of worsening heart condition and report any adverse events to your veterinarian.
For additional questions, 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: Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL Elixir, Oral for Veterinary Use Only

Model:

DIGOXI-SOL502VC

DIGOXISOL0005VC

Lot Numbers:

20121002@228 (BUD 03/31/2013)

20121009@233 (BUD 04/07/2013)

20121207@062 (BUD 06/07/2013)

20130107@298 (BUD 07/06/2013)

20130110@052 (BUD 07/06/2013)

20130306@086 (BUD 09/02/2013)

Product: Digoxin LS (0.15 mg/mL) Liver 150 mcg/mL Elixir, Oral for Veterinary Use Only

Model:

DIGOXI-SOL501VC

Lot Numbers:

20121101@195 (BUD 04/30/2013)

Product: Digoxin LS (0.05 mg/mL) Chicken 50 mcg/mL Elixir, Oral for Veterinary Use Only

Model:

DIGOXI-SOL003VC

DIGOXI-SOL0003VC

Lot Numbers:

20130108@042 (BUD 07/07/2013)

20130220@138 (BUD 08/19/2013)

Product: Digoxin (0.09 mg) Capsules, Oral for Veterinary Use Only

Model:

DIGOXI-CAP505VC

Lot Numbers:

20121023@117 (BUD 10/18/2013)

20121106@197 (BUD 11/01/2013)

Product: Digoxin (Flavored) 0.015 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS509VC

Lot Numbers:

201211022@246 (BUD 05/01/2013)

Product: Digoxin (Flavored) 0.002 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS506VC

Lot Numbers:

20121025@103 (BUD 04/23/2013)

Product: Digoxin (Flavored) 0.075 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS502VC

DIGOXISUS0006VC

Lot Numbers:

20121022@296 (BUD 04/20/2013)

20121120@307 (BUD 02/17/2013)

20121207@229 (BUD 06/05/2013)

Product: Digoxin (Flavored) 0.1 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS503VC

DIGOXISUS0011VC

Lot Numbers:

20121002@037 (BUD 03/31/2013)

20121127@313 (BUD 05/26/2013)

20130103@232 (BUD 07/02/2013)

20130130@060 (BUD 07/29/2013)

20130207@032 (BUD 08/06/2013)

20130304@337 (BUD 08/31/2013)

20130313@012 (BUD 09/09/2013)

Product: Digoxin (Flavored) 0.125 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS508VC

DIGOXISUS0030VC

Lot Numbers:

20121003@015 (BUD 04/01/2013)

20130219@021 (BUD 08/18/2013)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65185

Status: Resolved

Manufacturer: Wedgewood Village Pharmacy, Inc.

Sold By: Wedgewood Village Pharmacy, Inc.

Manufactured In: United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

Summary

What You Should Do

Check your pet's medication bottle for the following specific item codes: DIGOXI-SOL502VC, DIGOXISOL0005VC, DIGOXI-SOL501VC, DIGOXI-SOL003VC, DIGOXI-SOL0003VC, DIGOXI-CAP505VC, DIGOXI-SUS509VC, DIGOXI-SUS506VC, DIGOXI-SUS502VC, DIGOXISUS0006VC, DIGOXI-SUS503VC, DIGOXISUS0011VC, DIGOXI-SUS508VC, or DIGOXISUS0030VC.

Verify if your lot number is affected: for elixirs look for 20121002@228, 20121009@233, 20121207@062, 20130107@298, 20130110@052, 20130306@086, 20121101@195, 20130108@042, or 20130220@138; for capsules look for 20121023@117 or 20121106@197; for suspensions look for 201211022@246, 20121025@103, 20121022@296, 20121120@307, 20121207@229, 20121002@037, 20121127@313, 20130103@232, 20130130@060, 20130207@032, 20130304@337, 20130313@012, 20121003@015, or 20130219@021.

Contact your veterinarian or pharmacist immediately to discuss your pet's treatment and to obtain a replacement medication that meets potency standards.

Return any unused portion of the recalled medication to the pharmacy for a refund and contact Wedgewood Village Pharmacy at 856-467-2222 for further instructions.

Monitor your pet closely for any signs of worsening heart condition and report any adverse events to your veterinarian.

For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Affected Products

Product: Digoxin LS (0.05 mg/mL) Liver 50 mcg/mL Elixir, Oral for Veterinary Use Only

Model:

DIGOXI-SOL502VC

DIGOXISOL0005VC

Lot Numbers:

20121002@228 (BUD 03/31/2013)

20121009@233 (BUD 04/07/2013)

20121207@062 (BUD 06/07/2013)

20130107@298 (BUD 07/06/2013)

20130110@052 (BUD 07/06/2013)

20130306@086 (BUD 09/02/2013)

Product: Digoxin LS (0.15 mg/mL) Liver 150 mcg/mL Elixir, Oral for Veterinary Use Only

Model:

DIGOXI-SOL501VC

Lot Numbers:

20121101@195 (BUD 04/30/2013)

Product: Digoxin LS (0.05 mg/mL) Chicken 50 mcg/mL Elixir, Oral for Veterinary Use Only

Model:

DIGOXI-SOL003VC

DIGOXI-SOL0003VC

Lot Numbers:

20130108@042 (BUD 07/07/2013)

20130220@138 (BUD 08/19/2013)

Product: Digoxin (0.09 mg) Capsules, Oral for Veterinary Use Only

Model:

DIGOXI-CAP505VC

Lot Numbers:

20121023@117 (BUD 10/18/2013)

20121106@197 (BUD 11/01/2013)

Product: Digoxin (Flavored) 0.015 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS509VC

Lot Numbers:

201211022@246 (BUD 05/01/2013)

Product: Digoxin (Flavored) 0.002 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS506VC

Lot Numbers:

20121025@103 (BUD 04/23/2013)

Product: Digoxin (Flavored) 0.075 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS502VC

DIGOXISUS0006VC

Lot Numbers:

20121022@296 (BUD 04/20/2013)

20121120@307 (BUD 02/17/2013)

20121207@229 (BUD 06/05/2013)

Product: Digoxin (Flavored) 0.1 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS503VC

DIGOXISUS0011VC

Lot Numbers:

20121002@037 (BUD 03/31/2013)

20121127@313 (BUD 05/26/2013)

20130103@232 (BUD 07/02/2013)

20130130@060 (BUD 07/29/2013)

20130207@032 (BUD 08/06/2013)

20130304@337 (BUD 08/31/2013)

20130313@012 (BUD 09/09/2013)

Product: Digoxin (Flavored) 0.125 mg/mL Suspension, Oral, for Veterinary Use Only

Model:

DIGOXI-SUS508VC

DIGOXISUS0030VC

Lot Numbers:

20121003@015 (BUD 04/01/2013)

20130219@021 (BUD 08/18/2013)