The Recall Desk
SevereFDA (Drugs)·D-840-2013·Announced 2013-08-14

AstraZeneca Recalls Merrem I.V. Vials Due to Precipitate Presence

AstraZeneca is recalling specific lots of Merrem I.V. (meropenem) because of precipitate presence, which may prevent the medication from mixing completely.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a Severe severity score under the rubric for significant potential harm or significant injury reports.

Plain-English summary

AstraZeneca Pharmaceuticals LP is recalling 81,900 vials of MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial. The recall affects NDC 0310-321-30, specifically lot JX109 and lot JY042, both with an expiration date of 2/2015. The product was distributed in the USA and Puerto Rico.

The recall was initiated due to the presence of precipitate in the vials. This condition creates a potential for incomplete constitution, meaning the medication may not mix properly when the diluent is added. The FDA has classified this recall as Class II.

Healthcare providers and patients should stop using the affected lots of Merrem I.V. and contact their pharmacist or the recalling firm for further instructions. Consumers should not attempt to use the product if they have identified the specific lot numbers and expiration dates listed in this notice.

The recalled product

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 units
81,900

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • NDC 0310-321-30
  • lot JX109
  • expiration 2/2015
  • lot JY042

Distribution

Distributed in 1 state: