# FDA recall D-1085-2015

> **Boehringer Ingelheim Roxane Inc** · Class II · drug recall initiated 2015-04-02.

## 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 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1085-2015
- **Recalling firm:** Boehringer Ingelheim Roxane Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2015-04-02
- **Report date:** 2015-06-03
- **Termination date:** 2016-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2015

## Citation

> AI Analytics. FDA recall D-1085-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1085-2015. Source: US FDA. Licensed CC0.

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