The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0377-2015·Announced 2015-01-28

Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

Mylan Institutional, Inc. is recalling Ciprofloxacin Tablets 500 mg because they were produced with active ingredients 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 11,650 cartons of Ciprofloxacin Tablets, USP, 500 mg. The affected product is identified by NDC 51079-182-20, Lot Number 3034630, and an expiration date of 12/13.

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). The agency has classified this recall as Class II.

The product was distributed nationwide and in Puerto Rico. Consumers should check their medication for the specific lot number and NDC listed above. If the product matches the recalled lot, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Antibiotic
Hazard
Affected units
11,650

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 (3)

  • Lot Number: 3034630
  • Expiration Date: 12/13
  • NDC: 51079-182-20

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 2 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 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 2 products in this recall →

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