Drug recall D-840-2013

Class II Terminated reported Aug 14, 2013

Product

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

Reason for recall

Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

Lots and codes

NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015

Recall details

Recalling firm
AstraZeneca Pharmaceuticals LP, Wilmington, DE
Quantity
81,900 total vials
Distribution
USA and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
June 21, 2013
Terminated
January 29, 2015