Recalls / Class III
Class IIID-66373-001
Product
Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
- Affected lot / code info
- Lot #: BU3417, Exp 06/2014
Why it was recalled
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 25,830 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-25
- FDA classified
- 2013-10-10
- Posted by FDA
- 2013-10-16
- Terminated
- 2014-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66373-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.