Class III
Terminated
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.
This recall has been terminated (originally issued December 5, 2018).
- Company
- Remedyrepack Inc.
- Recall Initiated
- November 7, 2018
- Posted
- December 5, 2018
- Recall Number
- D-0284-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,148 capsules
- Firm Location
- Indiana, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Distribution
Product was distributed to two medical facilities in Pennsylvania.
Lot / Code Info
Lot #: B0484872-081718, B0481339-081018, Exp 08/2019; B0506246-092718, Exp 09/2019; B0509938-100418, Exp 10/2019
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