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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description PROIN 75MG COUNT BOTTLES HAVE THE CORRECT BASE LABEL OF: "***PROIN 75 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 75 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Each scored tablet contains 75 mg phenylpropanolamine, as hydrochloride.***Indications: PROIN is indicated for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.***Dosage: The total recommended dosage for oral administration is 2mg/kg (0.91 mg/lb) of body weight twice daily. Tablets are scored and dosage should be calculated in half-tablet increments.***Warnings: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. For use in dogs only.***Precautions: PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by: Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***" INCORRECT BOOKLET TOP LABEL IS A PROIN 25MG LABEL. INSERT/BOOKLET LABELING THAT MAY BE ON PROIN 75 mg 60 COUNT BOTTLES: "***PROIN 25 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 25 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Warnings: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. For use in dogs only.***Precautions: PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by: Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***" CORRECT BOOKLET TOP LABEL IS A PROIN 75 MG LABEL. INSERT/BOOKLET LABELING THAT SHOULD BE ON PROIN 75 mg 60 COUNT BOTTLES: "***PROIN 75 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 75 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Warnings: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. For use in dogs only.***Precautions: PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by: Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***"
Recall Number V-168-2012
Classification Class II
Code Info Lots: 120213 and 120416
Product Distributed Qty 34,685
Reason For Recall Pegasus Laboratories, Inc. is recalling 75 mg, 60 count bottles of Proin Lots 120416 and 120213 for misbranding. The affected product has the potential to have a 75mg base label with a 25mg Insert attached to the label. Proin is a veterinary drug used to treat incontinence in dogs.

Event Detail

Event Id 61940
Product Type Veterinary
Status Ongoing
Recalling Firm Pegasus Laboratories, Inc.
City Pensacola
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-24
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Product was distributed to FL, OR, OH, PA, CA, TX, MO, NY, MN, IA, NE, NJ.
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