Recalls / Class II
Class IID-0180-2020
Product
Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)
- Brand name
- Ranitidine Hydrochloride
- Generic name
- Ranitidine Hydrochloride
- Active ingredient
- Ranitidine Hydrochloride
- Route
- Oral
- NDCs
- 55111-129, 55111-130
- FDA application
- ANDA075742
- Affected lot / code info
- Batch Numbers: All lots within expiry.
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
Timeline
- Recall initiated
- 2019-10-01
- FDA classified
- 2019-11-05
- Posted by FDA
- 2019-11-13
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0180-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.