NDC 68071-3489
Fluorouracil 50 mg per 1 g cream
On the label: NuCare Pharmaceuticals.Inc.. It's repackaged: NuCare Pharmaceuticals.Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-4118.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd. | Haifa Bay, Israel | Makes it | No problems foundDec 8, 2022 · 7 inspections |
Repackaging site
- NuCare Pharmaceuticals,Inc., Orange, CA, United States · relabels it
Recalls
- Nov 21, 2012 · Class II · Taro Pharmaceuticals U.S.A., Inc.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Lots: Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp.…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluorouracil: every company that makes it
- Form
- cream
- Strength
- 50 mg per 1 g
- Approval
- ANDA ANDA090368
- On the market since
- Mar 5, 2010
- Package NDCs
68071-3489-4- Official label
- DailyMed (National Library of Medicine), updated Aug 24, 2023
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