Recalls / Class II
Class IID-0016-2021
Product
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
- Affected lot / code info
- Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- a) 54 bottles; b) 26 bottles
- Distribution pattern
- FL, GA
Timeline
- Recall initiated
- 2020-01-15
- FDA classified
- 2020-10-05
- Posted by FDA
- 2020-10-14
- Terminated
- 2020-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0016-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.