FDA Drug Recalls

Recalls / Class II

Class IID-514-2013

Product

Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10

Affected lot / code info
Lot # 11E002 Exp. 04/2013.

Why it was recalled

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Recalling firm

Firm
TG United, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
16275 Aviation Loop Dr, N/A, Brooksville, Florida 34604-6805

Distribution

Quantity
2957 bottles 100-count tablets
Distribution pattern
FL, MS, SC, LA and TX

Timeline

Recall initiated
2013-01-30
FDA classified
2013-06-04
Posted by FDA
2013-06-12
Terminated
2016-09-30
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-514-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.