Recalls / Class III
Class IIID-0695-2017
Product
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
- Affected lot / code info
- Lot #: 17C01-U07-036096, Exp. 5/1/2020
Why it was recalled
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, Saint Paul, Minnesota 55120-1118
Distribution
- Distribution pattern
- Nationwide within US
Timeline
- Recall initiated
- 2017-04-17
- FDA classified
- 2017-05-03
- Posted by FDA
- 2017-05-10
- Terminated
- 2017-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0695-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.