FDA Drug Recalls

Recalls / Class III

Class IIID-0810-2018

Product

Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00

Affected lot / code info
NDC 33261-0715-00 Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019

Why it was recalled

Presence of Foreign Tablets/Capsules

Recalling firm

Firm
Aidarex Pharmaceuticals LLC
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
595 N Smith Ave, Corona, California 92880-6920

Distribution

Quantity
450 bottles
Distribution pattern
Product was distributed to Florida

Timeline

Recall initiated
2018-04-10
FDA classified
2018-05-15
Posted by FDA
2018-05-23
Terminated
2019-12-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0810-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls