D-1035-2020 Class III Terminated
FDA drug recall D-1035-2020 was initiated by Par Pharmaceutical Inc. on March 4, 2020 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg The recall status is terminated (terminated April 9, 2021). Affected quantity: 13008 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 25, 2020
- Initiation Date
- March 4, 2020
- Termination Date
- April 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13008 bottles
Product Description
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Reason for Recall
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 8672518, Exp 12/21