Abbott Laboratories: OroCAM (meloxicam) Oral Spray Recalled for Incorrect Dosing Risk

Agency Publication Date: January 24, 2014

Summary

Abbott Animal Health is voluntarily recalling ten lots of OroCAM (meloxicam) Transmucosal Oral Spray for Dogs, involving approximately 41,937 vials in the United States and additional units internationally. The recall was initiated because certain vials from specific lots were found to have incorrect metered-dose pumps installed. This defect means dogs could receive an incorrect dose of medication during administration, which could lead to ineffective treatment or accidental overdose. Consumers should check their vial size and lot numbers to see if their pet's medication is affected.

Risk

Incorrect pump hardware can deliver the wrong amount of meloxicam per spray, potentially causing a dog to receive too much or too little medication, which may result in adverse health effects or a lack of necessary pain relief. No specific injuries or deaths were reported in the provided data, but the mechanical defect creates a direct risk of dosing errors.

What You Should Do

Identify if you have OroCAM (meloxicam) Transmucosal Oral Spray for Dogs by checking the vial size (6 mL, 11 mL, or 33 mL) and the lot numbers on the packaging.
Check 6 mL Vials (List 04943-04-01) for lot codes EMFG (Exp 11/2014), FBDN (Exp 02/2015), FEBU-3 (Exp 05/2015), or FEBU-1 (Exp 05/2015).
Check 11 mL Vials (List 04943-04-02) for lot codes EMFF (Exp 11/2014) or FEBU-2 (Exp 05/2015).
Check 13 mL Vials (List 04943-04-03) for lot codes EMFG-1, EMGL, EMGM, or EMGN, all with expiration dates of 11/2014.
If you have an affected product, contact your veterinarian or healthcare provider immediately for guidance on your dog's treatment and to report any side effects.
Return any unused product to the place of purchase for a refund and contact Abbott Animal Health at 100 Abbott Park Rd, Abbott Park, IL 60064 for further instructions.
For additional questions or to report concerns, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

Full Refund

Full refund for unused medication.

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

Affected Products

Product: OroCAM (meloxicam) Transmucosal Oral Spray (6 mL)

Model:

04943-04-01

Lot Numbers:

EMFG (Exp 11/2014)

FBDN (Exp 02/2015)

FEBU-3 (Exp 05/2015)

FEBU-1 (Exp 05/2015)

Date Ranges: 11/2014, 02/2015, 05/2015

Product: OroCAM (meloxicam) Transmucosal Oral Spray (11 mL)

Model:

04943-04-02

Lot Numbers:

EMFF (Exp 11/2014)

FEBU-2 (Exp 05/2015)

Date Ranges: 11/2014, 05/2015

Product: OroCAM (meloxicam) Transmucosal Oral Spray (13 mL)

Model:

04943-04-03

Lot Numbers:

EMFG-1 (Exp 11/2014)

EMGL (Exp 11/2014)

EMGM (Exp 11/2014)

EMGN (Exp 11/2014)

Date Ranges: 11/2014

Product: OroCAM (meloxicam) Transmucosal Oral Spray (Foreign 6 mL)

Model:

04943-90-01

04943-27-01

04943-03-01

Lot Numbers:

EDEG-2 (Exp 05-2014)

EKFE (Exp 9-2014)

EDEG (Exp 05-2014)

33008XN (Exp 10-2015)

33004XN (Exp 10-2015)

Date Ranges: 05-2014, 09-2014, 10-2015

Product: OroCAM (meloxicam) Transmucosal Oral Spray (Foreign 11 mL)

Model:

04943-90-02

04943-27-02

Lot Numbers:

EDEG-3 (Exp 05-2014)

EFKE-1 (Exp 09-2014)

EDGE-1 (Exp 05-2014)

Date Ranges: 05-2014, 09-2014

Product: OroCAM (meloxicam) Transmucosal Oral Spray (Foreign 33 mL)

Model:

04943-27-03

04943-90-03

Lot Numbers:

EDEH (Exp 05-2014)

EDEF (Exp 04-2014)

EHGM (Exp 08-2014)

EFFW (Exp 06-2014)

EHEK (Exp 09-2014)

Date Ranges: 04-2014, 05-2014, 06-2014, 08-2014, 09-2014

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67091

Status: Resolved

Manufacturer: Abbott Laboratories

Sold By: Veterinary clinics; Animal hospitals

Manufactured In: Spain

Units Affected: *** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.

Distributed To: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

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

Risk

What You Should Do

Identify if you have OroCAM (meloxicam) Transmucosal Oral Spray for Dogs by checking the vial size (6 mL, 11 mL, or 33 mL) and the lot numbers on the packaging.

Check 6 mL Vials (List 04943-04-01) for lot codes EMFG (Exp 11/2014), FBDN (Exp 02/2015), FEBU-3 (Exp 05/2015), or FEBU-1 (Exp 05/2015).

Check 11 mL Vials (List 04943-04-02) for lot codes EMFF (Exp 11/2014) or FEBU-2 (Exp 05/2015).

Check 13 mL Vials (List 04943-04-03) for lot codes EMFG-1, EMGL, EMGM, or EMGN, all with expiration dates of 11/2014.

If you have an affected product, contact your veterinarian or healthcare provider immediately for guidance on your dog's treatment and to report any side effects.

Return any unused product to the place of purchase for a refund and contact Abbott Animal Health at 100 Abbott Park Rd, Abbott Park, IL 60064 for further instructions.

For additional questions or to report concerns, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Affected Products

Product: OroCAM (meloxicam) Transmucosal Oral Spray (6 mL)

Model:

04943-04-01

Lot Numbers:

EMFG (Exp 11/2014)

FBDN (Exp 02/2015)

FEBU-3 (Exp 05/2015)

FEBU-1 (Exp 05/2015)

Date Ranges: 11/2014, 02/2015, 05/2015

Product: OroCAM (meloxicam) Transmucosal Oral Spray (11 mL)

Model:

04943-04-02

Lot Numbers:

EMFF (Exp 11/2014)

FEBU-2 (Exp 05/2015)

Date Ranges: 11/2014, 05/2015

Product: OroCAM (meloxicam) Transmucosal Oral Spray (13 mL)

Model:

04943-04-03

Lot Numbers:

EMFG-1 (Exp 11/2014)

EMGL (Exp 11/2014)

EMGM (Exp 11/2014)

EMGN (Exp 11/2014)

Date Ranges: 11/2014

Product: OroCAM (meloxicam) Transmucosal Oral Spray (Foreign 6 mL)

Model:

04943-90-01

04943-27-01

04943-03-01

Lot Numbers:

EDEG-2 (Exp 05-2014)

EKFE (Exp 9-2014)

EDEG (Exp 05-2014)

33008XN (Exp 10-2015)

33004XN (Exp 10-2015)

Date Ranges: 05-2014, 09-2014, 10-2015

Product: OroCAM (meloxicam) Transmucosal Oral Spray (Foreign 11 mL)

Model:

04943-90-02

04943-27-02

Lot Numbers:

EDEG-3 (Exp 05-2014)

EFKE-1 (Exp 09-2014)

EDGE-1 (Exp 05-2014)

Date Ranges: 05-2014, 09-2014

Product: OroCAM (meloxicam) Transmucosal Oral Spray (Foreign 33 mL)

Model:

04943-27-03

04943-90-03

Lot Numbers:

EDEH (Exp 05-2014)

EDEF (Exp 04-2014)

EHGM (Exp 08-2014)

EFFW (Exp 06-2014)

EHEK (Exp 09-2014)

Date Ranges: 04-2014, 05-2014, 06-2014, 08-2014, 09-2014

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67091

Status: Resolved

Manufacturer: Abbott Laboratories

Sold By: Veterinary clinics; Animal hospitals

Manufactured In: Spain

Units Affected: *** US PRODUCTS *** 6 mL Vials: 14,527 vials. 11 mL Vials: 14,104 vials. 33 mL Vials: 13,306 vials.