Status
Terminated
Drug Enforcement D-840-2013
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Classification
Class II
Report Date
August 14, 2013
Termination Date
January 29, 2015
Product Information
- 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
- Product quantity
- 81,900 total vials
- Reason for recall
- Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA and Puerto Rico
Location & Firm
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- Address
-
1800 Concord Pike, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-840-2013
- Event ID
- 65543
- Recall initiation date
- June 21, 2013
- Center classification date
- August 5, 2013
- Code info
- NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
- More code info
- —