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, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Lot numbers, UPCs & expiration codes
Lot #: 3084288, Exp. 07/18
Where it was sold
Nationwide in the USA
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-0622-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 21, 2017
- FDA report date
- Apr 5, 2017
- Quantity
- 1,527 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-0622-2017, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 76802
- Address
- 1718 Northrock Ct
- Code information
- Lot #: 3084288, Exp. 07/18
- Postal code
- 61103-1201
- Report date
- Apr 5, 2017
- Product type
- Drugs
- Recall number
- D-0622-2017
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 1,527 cartons
- Termination date
- Mar 15, 2019
- 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, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 21, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2017