Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
Reported: October 17, 2018 Initiated: September 26, 2018 #D-0088-2019
Product Description
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
Reason for Recall
CGMP deviations
Details
- Recalling Firm
- GLAXOSMITHKLINE NEBRASKA
- Units Affected
- 5,548,673 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lincoln, NE
Frequently Asked Questions
What product was recalled? ▼
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.. Recalled by GLAXOSMITHKLINE NEBRASKA. Units affected: 5,548,673 bottles.
Why was this product recalled? ▼
CGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 17, 2018. Severity: Moderate. Recall number: D-0088-2019.
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