Why it was recalled
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
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
Lot numbers, UPCs & expiration codes
NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
Where it was sold
USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-840-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 81,900 total vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AstraZeneca Pharmaceuticals LP
Original FDA data
Every field from FDA enforcement report D-840-2013, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 65543
- Address
- 1800 Concord Pike
- Code information
- NDC 0310-321-30, lot JX109, expiration 2/2015; lot JY042, expiration 2/2015
- Postal code
- 19850
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-840-2013
- Classification
- Class II
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- Product quantity
- 81,900 total vials
- Termination date
- Jan 29, 2015
- Reason for recall
- Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA and Puerto Rico
- Recall initiation date
- Jun 21, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2013