Why it was recalled
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Product description
Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01
Lot numbers, UPCs & expiration codes
Lot #: CB222A, Exp 06/16
Where it was sold
GA, AR
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-220-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 6, 2013
- FDA report date
- Apr 3, 2013
- Quantity
- 7,136 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-220-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64100
- Address
- 465 Industrial Way W
- Code information
- Lot #: CB222A, Exp 06/16
- Postal code
- 07724-2209
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-220-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 7,136 units
- Termination date
- Aug 4, 2014
- Reason for recall
- Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01
- Distribution pattern
- GA, AR
- Recall initiation date
- Feb 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 27, 2013