Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
Reported: November 20, 2019 Initiated: October 28, 2019 #D-0309-2020
Product Description
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Lannett Company, Inc.
- Units Affected
- 683,149 bottles
- Distribution
- Nationwide
- Location
- Philadelphia, PA
Frequently Asked Questions
What product was recalled? ▼
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80. Recalled by Lannett Company, Inc.. Units affected: 683,149 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0309-2020.
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