Class III · Low risk
Magnesium Chloride
Subpotent drug
NEXIUM¿ (esomeprazole magnesium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
Affected NDC
0186-5020-31
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium Category: Heartburn & Stomach Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nexium Esomeprazole magnesium NDC 00186-5020 |
TRIHYDRATE 20 mg/1 | Capsule, Delayed Release Oral |
AstraZeneca Pharmaceuticals LP | Rx |
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- NDC code
- 00186-5020-31
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1141-2015 · 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 Magnesium recalls
See all
Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Other recalls by AstraZeneca Pharmaceuticals LP
All 2015 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
Merrem I.V.
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
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