Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
Reported: November 13, 2019 Initiated: October 1, 2019 #D-0175-2020
Product Description
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- N/A
- Distribution
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: N/A.
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 13, 2019. Severity: Moderate. Recall number: D-0175-2020.
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