Reported Jun 3, 2015 · Completed
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories,…
Boehringer Ingelheim Roxane Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- 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
- Lot codes and dates
- a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
- Amount recalled
- a) 575 Blister Packs, b) 12,802 Bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
This product could cause temporary or reversible health problems — stop using it.
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