# FDA recall D-1320-2019

> **Lupin Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-05-23.

## Product

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20

## Reason for recall

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1320-2019
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-23
- **Report date:** 2019-06-05
- **Termination date:** 2020-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1320-2019

## Citation

> AI Analytics. FDA recall D-1320-2019. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-1320-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
