NDC 43353-317
Tacrolimus 1 mg capsule
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Mylan Pharmaceuticals Inc.'s NDC 0378-2046.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Mylan Pharmaceuticals Inc. names for other drugs.
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Mar 23, 2020 · Class III · Mylan Pharmaceuticals Inc.
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Lots: Lot # 3105410, 3106268, Exp 9/2020 - Jun 29, 2012 · Class II · Mylan LLC.
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Lots: Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Tacrolimus: every company that makes it
- Form
- capsule, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA090596
- On the market since
- Nov 18, 2015
- Package NDCs
43353-317-09- Official label
- DailyMed (National Library of Medicine), updated May 3, 2017
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?