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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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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
Distribution Pattern USA and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015 Class II Presence of Precipitate; potential for incomplete constitution upon addition of diluent. 81,900 total vials D-840-2013