CLASS II Drug recall · Reported 14 Dec 2022 · FDA Enforcement Report
Desmopressin Acetate Tablet, 0.2 mg recalled by RemedyRepack
RemedyRepack is recalling Desmopressin Acetate Tablet, 0.2 mg, distributed in Michigan. The recall was initiated on 5 Dec 2022 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-0077-2023
- FDA event ID
- 91263
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2022
- FDA classified
- 7 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Dec 2022 | Recall initiated by company | |
| 7 Dec 2022 | Classified by FDA | +2 days |
| 14 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
Where it was distributed
Product was distributed to two different customers in MI.
Questions about this recall
Why was it recalled?
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Which lots are affected?
Lot # B1817019-082222, Exp. 02/24/2023; B1819127-082322, Exp. 02/26/2023
Where was it sold?
Product was distributed to two different customers in MI.
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 26 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 recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
Other Desmopressin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablets 0.2mg recalled by Heritage PharmaceuticalsDesmopressin Acetate | Heritage Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablets, 0.2 mg recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | TX |
| Drug | CLASS II | Desmopressin Acetate Injection USP, 4 mcg/mL Preserved Vial recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Desmopressin Acetate Nasal Spray 10 mcg/ glass vial with spray cap recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |