Nitrofurantoin Monohydrate/Macrocrystals capsules — Class III drug recall D-0284-2019
Terminated recall by RemedyRepack Inc., reported 2018-12-05, distributed in PA. Cross contamination with other products: Product is being recalled due to the potential presence of unrelated
| Recall number | D-0284-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2018-11-07 |
| Classified | 2018-11-27 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2019-04-01 |
| Distributed | PA |
| Quantity | 3,148 capsules |
| NDC | 00185-0122-01, 70518-1087-00, 70518-1087-01 |
| Lot numbers | B0481339-081018, B0484872-081718, B0506246-092718, B0509938-100418 |
| Expiration dates | 2019-08, 2019-09, 2019-10 |
Product
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard trays & HDPE 60 cc bottles in plastic bags, Repackaged NDC 70518-1087-01, 10 capsules in HDPE 60 cc bottles in cardboard trays.
Reason for recall
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0284-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.