The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-011·Announced 2013-11-13

Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling Ciprofloxacin 500 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 recall is classified as FDA Class II, which per the rubric corresponds to a score of 4 (Severe) when associated with significant injury or property damage reports, or generally high-risk scenarios where the agency has not downgraded to Class III.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Ciprofloxacin Tablets, USP, 500 mg, 100-count bottles (NDC 0378-7098-01). The recall involves 941,270 bottles distributed nationwide and in Puerto Rico.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients that were not manufactured according to Good Manufacturing Practices (CGMP Deviations). This classification indicates a potential risk of adverse health consequences, though the source text does not specify reported illnesses or injuries.

Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The specific lot numbers affected are listed in the recall documentation.

The recalled product

Product
Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Antibiotic
Hazard
Affected units
941,270

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 (20)

  • Lot #: 2002732
  • 2002733
  • 2002734
  • 2002735
  • 2002736
  • 2002737
  • 2002738
  • 2002739
  • 2002740
  • 2002741
  • 2002742
  • 2002743
  • 2002744
  • 2002745
  • 3030000
  • 3030001
  • 3030002
  • 3030003
  • 3030004
  • 3030005

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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