Ranitidine Tablets recalled over manufacturing violations
- Recall date
- October 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Dr. Reddy's Laboratories, Inc. recalls Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
- Recall number
- D-0169-2020
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720
Get recall alerts
Free email alert whenever Dr. Reddy's Laboratories, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Dr. Reddy's Laboratories, Inc.