# FDA recall D-1069-2014

> **PACK Pharmaceuticals, LLC** · Class III · drug recall initiated 2013-09-09.

## Product

Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11).    The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip.  The filled bottles are individually packaged into fiberboard cartons.

## Reason for recall

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-1069-2014
- **Recalling firm:** PACK Pharmaceuticals, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-09
- **Report date:** 2014-02-12
- **Termination date:** 2014-04-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1069-2014

## Citation

> AI Analytics. FDA recall D-1069-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1069-2014. Source: US FDA. Licensed CC0.

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