Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Reported: September 14, 2016 Initiated: February 19, 2016 #D-1493-2016
Product Description
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Details
- Recalling Firm
- Lupin Limited
- Units Affected
- 11,812 bottles
- Distribution
- US No recalled product was distributed to any foreign consignees by Lupin.
- Location
- Verna, Salcette, Goa
Frequently Asked Questions
What product was recalled? ▼
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03. Recalled by Lupin Limited. Units affected: 11,812 bottles.
Why was this product recalled? ▼
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2016. Severity: Low. Recall number: D-1493-2016.
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