Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
Reported: November 13, 2019 Initiated: October 1, 2019 #D-0168-2020
Product Description
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)
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? ▼
Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05). 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-0168-2020.
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