Recalls / Class III
Class IIID-1057-2020
Product
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
- Brand name
- Tacrolimus
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 0378-2045, 0378-2046, 0378-2047
- FDA application
- ANDA090596
- Affected lot / code info
- Lot # 3105410, 3106268, Exp 9/2020
Why it was recalled
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 3,816 botlles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-03-23
- FDA classified
- 2020-03-24
- Posted by FDA
- 2020-04-01
- Terminated
- 2021-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1057-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.