Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Product description
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Lot numbers, UPCs & expiration codes
Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14
Where it was sold
Nationwide, Puerto Rico and Guam
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-1468-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 17, 2013
- FDA report date
- Aug 31, 2016
- Quantity
- a) 11,064 cartons; b) 2,052 cartons; c) 5,567 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-1468-2016, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66393
- Address
- 1718 Northrock Ct
- Code information
- Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14
- Postal code
- 61103-1201
- Report date
- Aug 31, 2016
- Product type
- Drugs
- Recall number
- D-1468-2016
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
- Termination date
- Apr 24, 2018
- Reason for recall
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
- Distribution pattern
- Nationwide, Puerto Rico and Guam
- Recall initiation date
- Sep 17, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2016