FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Reported: October 21, 2015 Initiated: September 25, 2015 #D-0011-2016
Product Description
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Reason for Recall
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 11,110 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 11,110 bottles.
Why was this product recalled? ▼
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2015. Severity: Low. Recall number: D-0011-2016.
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