D-0695-2017 Class III Terminated
FDA drug recall D-0695-2017 was initiated by Fagron, Inc on April 17, 2017 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated August 11, 2017).
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2017
- Initiation Date
- April 17, 2017
- Termination Date
- August 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
Reason for Recall
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.
Distribution Pattern
Nationwide within US
Code Information
Lot #: 17C01-U07-036096, Exp. 5/1/2020