CLASS II ONGOING Drug recall · Reported 24 May 2023 · FDA Enforcement Report
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card recalled
RemedyRepack is recalling Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, distributed in Pennsylvania. The recall was initiated on 1 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0578-2023
- FDA event ID
- 92239
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2023
- FDA classified
- 16 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 1 May 2023 | Recall initiated by company | |
| 16 May 2023 | Classified by FDA | +15 days |
| 24 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Product as listed by the FDA
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
Where it was distributed
Product was distrituded to three direct account in PA.
Questions about this recall
Is Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card recalled?
Yes. RemedyRepack recalled Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card on 1 May 2023. The recall is Class II and its status is Ongoing. Recall number D-0578-2023.
Why was it recalled?
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Which lots are affected?
Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
Where was it sold?
Product was distrituded to three direct account in PA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq K recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |