CLASS II Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Merrem I.V. (meropenem for injection) meropenem equivalent vial recalled
AstraZeneca Pharmaceuticals is recalling Merrem I.V. (meropenem for injection) meropenem equivalent vial, distributed in Puerto Rico. The recall was initiated on 21 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-840-2013
- FDA event ID
- 65543
- Recalling firm
- AstraZeneca Pharmaceuticals, Wilmington, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2013
- FDA classified
- 5 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antibiotics
Timeline
| 21 Jun 2013 | Recall initiated by company | |
| 5 Aug 2013 | Classified by FDA | +45 days |
| 14 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Product as listed by the FDA
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
Where it was distributed
USA and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Which lots are affected?
NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
Where was it sold?
USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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