# FDA recall D-1112-2018

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class III · drug recall initiated 2018-08-14.

## Product

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

## Reason for recall

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1112-2018
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-14
- **Report date:** 2018-08-29
- **Termination date:** 2020-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1112-2018

## Citation

> AI Analytics. FDA recall D-1112-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-1112-2018. Source: US FDA. Licensed CC0.

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