Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per recall: Subpotent
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…
Why was Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per recalled?
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
- Product
- 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…
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- June 3, 2015
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)