Recalls / Class III
Class IIID-1035-2020
Product
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
- Brand name
- Prednisone
- Generic name
- Prednisone
- Active ingredient
- Prednisone
- Route
- Oral
- NDCs
- 0603-5335, 0603-5336, 0603-5337, 0603-5338, 0603-5339
- FDA application
- ANDA040584
- Affected lot / code info
- Lot #: 8672518, Exp 12/21
Why it was recalled
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Recalling firm
- Firm
- Par Pharmaceutical Inc.
- Manufacturer
- Endo USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 13008 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-03-04
- FDA classified
- 2020-03-18
- Posted by FDA
- 2020-03-25
- Terminated
- 2021-04-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1035-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.