Why it was recalled
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Product description
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Lot numbers, UPCs & expiration codes
Lot # 3105410, 3106268, Exp 9/2020
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1057-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 23, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 3,816 botlles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1057-2020, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 85273
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 3105410, 3106268, Exp 9/2020
- Postal code
- 26505-2730
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1057-2020
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 3,816 botlles
- Termination date
- Jul 7, 2021
- Reason for recall
- Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 24, 2020