Why it was recalled
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Product description
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Lot numbers, UPCs & expiration codes
Lot #: 8672518, Exp 12/21
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1035-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 4, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 13008 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-1035-2020, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85136
- Address
- 1 Ram Ridge Rd
- Code information
- Lot #: 8672518, Exp 12/21
- Postal code
- 10977-6714
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1035-2020
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical Inc.
- Product quantity
- 13008 bottles
- Termination date
- Apr 9, 2021
- Reason for recall
- Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 4, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2020