June 2013 FDA Recall Drug by Astrazeneca Pharmaceuticals Lp
D-840-2013 - Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

This Class II drug recall was voluntarily initiated by Astrazeneca Pharmaceuticals Lp on June 21, 2013 for the product Drug. The FDA reported the reason for recall as presence of precipitate; potential for incomplete constitution upon addition of diluent.. The product was distributed in USA and Puerto Rico and the recall is currently terminated.

Recall Number: D-840-2013

Reason for Recall
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Initiated
06-21-2013
Reported
08-14-2013
Quantity
81,900 total vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65543
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AstraZeneca Pharmaceuticals LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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