Why it was recalled
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Product description
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Lot numbers, UPCs & expiration codes
Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Where it was sold
Natiowide
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-066-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2012
- FDA report date
- Dec 5, 2012
- Quantity
- 15181 bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan LLC.
Original FDA data
Every field from FDA enforcement report D-066-2013, exactly as published.
Show all FDA fields
- City
- Caguas
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 62454
- Address
- Road #156, Km. 58.8, Lot 24B
- Code information
- Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
- Postal code
- 00725
- Report date
- Dec 5, 2012
- Product type
- Drugs
- Recall number
- D-066-2013
- Classification
- Class II
- Recalling firm
- Mylan LLC.
- Product quantity
- 15181 bottles.
- Termination date
- Apr 13, 2017
- Reason for recall
- Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
- Distribution pattern
- Natiowide
- Recall initiation date
- Jun 29, 2012
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2012