# FDA recall D-1416-2015

> **Silarx Pharmaceutical, Inc.** · Class III · drug recall initiated 2015-08-21.

## Product

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1416-2015
- **Recalling firm:** Silarx Pharmaceutical, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-21
- **Report date:** 2015-09-09
- **Termination date:** 2015-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carmel, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1416-2015

## Citation

> AI Analytics. FDA recall D-1416-2015. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1416-2015. Source: US FDA. Licensed CC0.

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