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Recall Observatory FDA recall evidence

Drug 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

D-840-2013

June 21, 2013

Class II

Product summary

Firm
AstraZeneca Pharmaceuticals LP
Event
Event 65543
Status
Terminated
Classification
Class II
Quantity
81,900 total vials
Official record key
drug-enforcement:D-840-2013

Official wording

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

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

Distribution pattern: USA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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