The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-004·Announced 2013-11-13

Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling 521 bottles of Ciprofloxacin 250 mg tablets because they were not manufactured according to Good Manufacturing Practices.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), as the agency's own classification mandates a minimum score of 4.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 521 bottles of Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles (NDC 0378-7097-01). The affected lots are 3032075 and 3032076. The products were distributed nationwide and in Puerto Rico.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices (CGMP Deviations). This classification is designated as Class II by the FDA.

Consumers who have these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Antibiotic
Hazard
Affected units
521

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 #: 3032075
  • 3032076

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Mylan Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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