Recall record at a glance
| Official record | D-0284-2019 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | RemedyRepack Inc. |
| Report date | Dec 5, 2018 |
| Recall initiation date | Nov 7, 2018 |
| Quantity | 3,148 capsules |
| Location | Indiana, PA, United States |
Official product description
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.
Why the product was recalled
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Distribution information
Product was distributed to two medical facilities in Pennsylvania.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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