The Recall Desk
SevereFDA (Drugs)·D-1141-2015·Announced 2015-06-24

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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.