FDA Drug recall D-1035-2020
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
- FDA Drug
- Class III
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class III recall of PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31 by Par Pharmaceutical, citing labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1035-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-03-04 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Par Pharmaceutical |
| Distribution | US |
Product
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Reason
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Identifiers
| ndc | 0603-5335-21 |
|---|---|
| ndc | 0603-5335-32 |
| ndc | 0603-5336-21 |
| ndc | 0603-5337-21 |
| ndc | 0603-5337-32 |
| ndc | 0603-5337-15 |
| ndc | 0603-5337-31 |
| ndc | 0603-5338-21 |
| ndc | 0603-5338-28 |
| ndc | 0603-5338-32 |
| ndc | 0603-5338-15 |
| ndc | 0603-5338-31 |
| ndc | 0603-5339-21 |
| ndc | 0603-5339-28 |
| ndc | 0603-5339-32 |
| code_info | Lot #: 8672518, Exp 12/21 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2020-09-02 · Par Pharmaceutical - Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par F…
FDA Drug · Class II · 2020-04-08 · Par Pharmaceutical - Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services…
FDA Drug · Class III · 2020-02-19 · Par Pharmaceutical - Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977…
FDA Drug · Class I · 2019-05-15 · Par Pharmaceutical - Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical,…
FDA Drug · Class III · 2018-09-19 · Par Pharmaceutical
All Par Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1035-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.