Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Reported: October 14, 2020 Initiated: January 15, 2020 #D-0017-2021
Product Description
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Direct Rx
- Units Affected
- 26 bottles
- Distribution
- FL, GA
- Location
- Dawsonville, GA
Frequently Asked Questions
What product was recalled? ▼
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30. Recalled by Direct Rx. Units affected: 26 bottles.
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 October 14, 2020. Severity: Moderate. Recall number: D-0017-2021.
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