NEXIUM Capsules Recalled Due to Presence of SEROQUEL XR Tablets
AstraZeneca is recalling NEXIUM capsules because a retail pharmacist found SEROQUEL XR tablets in an unopened bottle.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a different medication (SEROQUEL XR) in a NEXIUM bottle poses a significant risk of serious injury or adverse health consequences due to incorrect medication administration.
Plain-English summary
AstraZeneca Pharmaceuticals LP is recalling NEXIUM (esomeprazole magnesium) Delayed-Release capsules, 20 mg, 30-count bottles. The recall is due to a confirmed customer complaint from a retail pharmacist who found 60 SEROQUEL XR tablets inside an unopened bottle labeled as NEXIUM capsules.
The affected product is identified by Lot # FC0064 and an expiration date of 05/17. The NDC number is 00186-5020-31. A total of 34,524 bottles were distributed nationwide to wholesalers for further distribution at the retail level.
Consumers should check their NEXIUM bottles for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- 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.
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Category
- Drug — Prescription Medication
- Affected units
- 34,524
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 # FC0064
- Exp. 05/17
Distribution
Distributed nationwide across the United States.
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