FDA-Drug2014-08-13Class II
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Caraco Pharmaceutical Laboratories, Ltd.
Hazard
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Sold states
Nationwide and Puerto Rico
Affected count
a) 43,585 bottles; b) 296,968 bottles
Manufactured in
1150 Elijah McCoy Dr, N/A, Detroit, MI, United States
Products
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1511-2014Don't want to check this manually?
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