AstraZeneca Recalls Nexium Capsules Due to Foreign Product Contamination
AstraZeneca is recalling 2,556 bottles of Nexium 40 mg capsules because some may contain Nexium 20 mg capsules intended for the Japanese market.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is typically a score of 1 or 2. It is scored as 2 (Moderate) because it involves a contamination/mislabeling issue (foreign product) that is a minor labeling/packaging error rather than a cosmetic defect, but is unlikely to cause serious harm.
Plain-English summary
AstraZeneca LP is recalling 2,556 bottles of Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count. The recall is due to the presence of foreign tablets or capsules; specifically, some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addition to the intended Nexium 40 mg capsules.
The affected product is identified by Lot # H008328 with an expiration date of 11/14. The product was distributed nationwide. The NDC for the recalled package is 0186-5040-85.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- NEXIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- NEXIUM
- Manufacturer
- ASTRA ZENECA Lp
- Category
- Drug — Prescription Drug
- Affected units
- 2,556
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 (2)
- Lot #: H008328
- Exp 11/14
UPCs (1)
- 301865040850
Distribution
Distributed nationwide across the United States.
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