FDA Drug Recalls

Recalls / Class II

Class IID-1877-2019

Product

Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09

Affected lot / code info
Lot #: G0219K, Exp 3/2021; C1419E, Exp 3/2021

Why it was recalled

Failed Impurities/Degradation Specifications

Recalling firm

Firm
Preferred Pharmaceuticals, Inc
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801

Distribution

Quantity
79 (90 ct.) bottles
Distribution pattern
Product was distributed to 1 physician in Gainesville Florida.

Timeline

Recall initiated
2019-08-29
FDA classified
2019-09-24
Posted by FDA
2019-10-02
Terminated
2023-04-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1877-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls