Why it was recalled
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Product description
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Lot numbers, UPCs & expiration codes
Lot #: a) 3073782, 3073783, Exp 02/18; 3074915, 3074916, 3074917, Exp 03/18; 3074918, 3075572, Exp 04/18; 3075573, 3075574, Exp 05/18; 2007226, 3075894, Exp 06/18; 2007344, 2007345, 2007346, Exp 08/18; 2007451, 2007452, 2007453, 2007454, Exp 09/18; b) 3070840, Exp 10/17; 3073781, 3074911, Exp 02/18; 3074912, 3074913, 3074914, Exp 03/18; 3075570, 3075571, Exp 04/18; 3075892, Exp 05/18; 3075893, Exp 06/18; 2007341, 2007342, 2007343, 2007347, Exp 08/18; 2007456, Exp 10/18
Where it was sold
Nationwide in the USA and Puerto Rico
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-0621-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 20, 2017
- FDA report date
- Apr 5, 2017
- Quantity
- 452,269 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0621-2017, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 76750
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: a) 3073782, 3073783, Exp 02/18; 3074915, 3074916, 3074917, Exp 03/18; 3074918, 3075572, Exp 04/18; 3075573, 3075574, Exp 05/18; 2007226, 3075894, Exp 06/18; 2007344, 2007345, 2007346, Exp 08/18; 2007451, 2007452, 2007453, 2007454, Exp 09/18; b) 3070840, Exp 10/17; 3073781, 3074911, Exp 02/18; 3074912, 3074913, 3074914, Exp 03/18; 3075570, 3075571, Exp 04/18; 3075892, Exp 05/18; 3075893, Exp 06/18; 2007341, 2007342, 2007343, 2007347, Exp 08/18; 2007456, Exp 10/18
- Postal code
- 26505-2730
- Report date
- Apr 5, 2017
- Product type
- Drugs
- Recall number
- D-0621-2017
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 452,269 bottles
- Termination date
- Jan 26, 2018
- Reason for recall
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 20, 2017
- Initial firm notification
- Telephone
- Center classification date
- Mar 28, 2017