MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: As...

FDA Drug Recall #D-840-2013 — Class II — June 21, 2013

Recall Summary

Recall Number D-840-2013
Classification Class II — Moderate risk
Date Initiated June 21, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm AstraZeneca Pharmaceuticals LP
Location Wilmington, DE
Product Type Drugs
Quantity 81,900 total vials

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

Reason for Recall

Presence of Precipitate; potential for incomplete constitution upon addition of diluent.

Distribution Pattern

USA and Puerto Rico

Lot / Code Information

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

Other Recalls from AstraZeneca Pharmaceuticals LP

Recall # Classification Product Date
D-0585-2018 Class III Lynparza (olaparib) capsules 50 mg, 112 count b... Feb 23, 2018
D-0781-2016 Class II Tudorza Pressair (aclindinium bromide inhalatio... Feb 5, 2016
D-1141-2015 Class II NEXIUM¿ (esomeprazole magnesium), Delayed-Relea... Jun 10, 2015

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.