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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Sparhawk Laboratories, Inc. Atropine Sulfate 1/120 Injectable Solution, each mL of sterile solution contains 0.54 mg. atropine sulfate, packaged in 100-ml. vials, RX, Manufactured for Sparhawk Laboratories, Inc., Lenexa, KS.
Recall Number V-311-2013
Classification Class II
Code Info Lot number 120078, Exp. 11/2013
Product Distributed Qty 7,228/100-ml. vials
Reason For Recall The lot failed stability at the 12-mo. testing interval (low).

Event Detail

Event Id 65986
Product Type Veterinary
Status Ongoing
Recalling Firm Sparhawk Laboratories Inc
City Lenexa
State KS
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distribution was made to MO and OH.
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