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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30
Recall Number D-840-2013
Classification Class II
Code Info NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
Product Distributed Qty 81,900 total vials
Reason For Recall Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

Event Detail

Event Id 65543
Product Type Drugs
Status Ongoing
Recalling Firm AstraZeneca Pharmaceuticals LP
City Wilmington
State DE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA and Puerto Rico