FDA recall D-840-2013

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.

Distribution

USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-06-21

Report date

2013-08-14

Termination date

2015-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-840-2013