Recalls / Class II
Class IID-0586-2021
Product
TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10
- Affected lot / code info
- 200340H1
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 86 BOTTLE
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0586-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.