Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Product description
CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
Lot numbers, UPCs & expiration codes
Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20
Where it was sold
Nationwide 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-0377-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2013
- FDA report date
- Jan 28, 2015
- Quantity
- 11,650 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-0377-2015, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66607
- Address
- 1718 Northrock Ct
- Code information
- Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20
- Postal code
- 61103-1201
- Report date
- Jan 28, 2015
- Product type
- Drugs
- Recall number
- D-0377-2015
- Classification
- Class II
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 11,650 cartons
- Termination date
- Nov 9, 2015
- 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
- CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Sep 26, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 21, 2015