Key Takeaway

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 ND by AstraZeneca Pharmaceuticals LP was recalled on June 21, 2013. The hazard: Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

FDA Drug Class II Terminated

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 ND

Recalled: June 21, 2013 ~81,900 total vials units affected D-840-2013

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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 ND

Drugs

Company Information

AstraZeneca Pharmaceuticals LP

Wilmington, DE, United States

View all 5 recalls by AstraZeneca Pharmaceuticals LP →

Distribution

USA and Puerto Rico

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