Drug recall D-0180-2020

Class II Completed reported Nov 13, 2019

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)

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Lots and codes

Batch Numbers: All lots within expiry.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
N/A
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Type
Voluntary: Firm initiated
Recall initiated
October 1, 2019

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