Pack Pharmaceuticals Recalls Ciprofloxacin Tablets Due to Missing Labels
Pack Pharmaceuticals is voluntarily recalling 4,848 bottles of Ciprofloxacin 500 mg tablets because two bottles were found missing container labels.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a packaging/labeling defect (missing labels) rather than a contamination or safety hazard, which aligns with the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Pack Pharmaceuticals, LLC is voluntarily recalling 4,848 bottles of Ciprofloxacin Tablets, USP, 500 mg. The product is distributed nationwide and is identified by Lot # PUB1040 with an expiration date of 08/2015. The NDC for the recalled product is 16571-412-10.
The recall was initiated because two bottles of the product were found missing their container labels, rendering the labeling illegible. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this specific lot of Ciprofloxacin tablets should check their bottles for missing labels. If the label is missing, they should contact Pack Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- CIPROFLOXACIN (CIPROFLOXACIN)
- Brand
- CIPROFLOXACIN
- Manufacturer
- Pack Pharmaceuticals
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 4,848
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 #: : PUB1040
- Exp 08/2015
UPCs (2)
- 0316577411102
- 0316571412501
Distribution
Distributed nationwide across the United States.
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