Class II · Moderate risk
Meropenem
Lack of sterility assurance
Merrem I.V.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Drug: Meropenem
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-840-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Meropenem recalls
See all
Class II · Moderate risk
Meropenem for Injection
Lack of assurance of sterility: loss of container integrity.
Class II · Moderate risk
Meropenem 2 grams in 100 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
Meropenem 1 g/NS 100 mL Minibag Plus
Lack of Assurance of Sterility
Class II · Moderate risk
MEROPENEM in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Other recalls by AstraZeneca Pharmaceuticals LP
All 2013 recalls
Class III · Low risk
Lynparza (olaparib)
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class I · High risk
BRILINTA (ticagrelor)
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class II · Moderate risk
Tudorza Pressair
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Class II · Moderate risk
NEXIUM¿ (esomeprazole magnesium)
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.