FDA Drug recall D-0284-2019
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repacka…
- FDA Drug
- Class III
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class III recall of Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repacka… by Remedyrepack, citing cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0284-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-07 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | PA |
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
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Identifiers
| code_info | Lot #: B0484872-081718, B0481339-081018, Exp 08/2019; B0506246-092718, Exp 09/2019; B0509938-100418, Exp 10/2019 |
|---|
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 · 2025-01-01 · Remedyrepack - Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repac…
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0284-2019%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.