Ciprofloxacin Tablets Recalled for Foreign Material Presence
West-ward Pharmaceutical Corp. is recalling Ciprofloxacin 500 mg tablets due to a complaint of rubber-like material found in a tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign substance (rubber-like material) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling Ciprofloxacin Tablets USP, 500 mg, 100-count bottles (NDC 0143-9928-01). The recall was initiated after a complaint was received regarding the presence of a rubber-like material in a 500 mg Ciprofloxacin tablet.
The affected product is Lot # CB222A with an expiration date of 06/16. A total of 7,136 units were distributed to Georgia and Arkansas. The product is a prescription-only medication manufactured for West-ward Pharmaceutical Corp. by Hikma Pharmaceuticals.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for a replacement or further instructions.
The recalled product
- Product
- CIPROFLOXACIN (CIPROFLOXACIN)
- Brand
- CIPROFLOXACIN
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 7,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: CB222A
- Exp 06/16
Distribution
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