Recalls / Class II
Class IID-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
- Affected lot / code info
- NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
Why it was recalled
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Recalling firm
- Firm
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1800 Concord Pike, N/A, Wilmington, Delaware 19850
Distribution
- Quantity
- 81,900 total vials
- Distribution pattern
- USA and Puerto Rico
Timeline
- Recall initiated
- 2013-06-21
- FDA classified
- 2013-08-05
- Posted by FDA
- 2013-08-14
- Terminated
- 2015-01-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-840-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.