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
Reported: June 3, 2015 Initiated: April 2, 2015 #D-1085-2015
Product Description
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
Reason for Recall
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- a) 575 Blister Packs, b) 12,802 Bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: a) 575 Blister Packs, b) 12,802 Bottles.
Why was this product recalled? ▼
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 3, 2015. Severity: Moderate. Recall number: D-1085-2015.
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