D-840-2013 Class II Terminated
FDA drug recall D-840-2013 was initiated by AstraZeneca Pharmaceuticals LP on Jun 21, 2013 and is designated Class II. Reason for recall: Presence of Precipitate; potential for incomplete constitution upon addition of diluent. The recall status is terminated (terminated Jan 29, 2015). Affected quantity: 81,900 total vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 14, 2013
- Initiation Date
- Jun 21, 2013
- Termination Date
- Jan 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,900 total vials
Product 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
Reason for Recall
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Distribution Pattern
USA and Puerto Rico
Code Information
NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-840-2013
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026