FDA-Drug2015-06-03Class II
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
Boehringer Ingelheim Roxane Inc
Hazard
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Sold states
Nationwide and Puerto Rico
Affected count
a) 575 Blister Packs, b) 12,802 Bottles
Manufactured in
1809 Wilson Rd, Columbus, OH, United States
Products
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2015Don't want to check this manually?
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