The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-747-2014·Announced 2014-01-29

Teva Recalls Fluconazole Oral Suspension for Low Preservative Content

Teva Pharmaceuticals is recalling Fluconazole Oral Suspension because the product has preservative levels below the required specification.

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 FDA classified this as a Class III recall, which is defined as a situation unlikely to cause adverse health consequences. The issue is a failure to meet stability specifications for preservative content.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottles. The product is manufactured by Cipla, Ltd., in Goa, India, and distributed by Teva. The recall involves 234,242 bottles distributed nationwide.

The recall was initiated because the product failed stability specifications, specifically having preservative content below the required level. The affected lots include various expiration dates ranging from November 2013 to May 2015.

Consumers and healthcare providers should check their inventory for the specific NDC 0093-5414-95 and the listed lot numbers. If the product is found, it should be returned to the pharmacy or distributor for credit or replacement.

The recalled product

Product
Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Antifungal
Hazard
Affected units
234,242

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: (Exp)
  • V10316 (11/13)
  • V10317 (11/13)
  • V10320 (11/13)
  • V10321 (11/13)
  • V20086 (2/14)
  • V20087 (2/14)
  • V20089 (2/14)
  • V20093 (2/14)
  • V20094 (2/14)
  • V20118 (3/14)
  • V20119 (3/14)
  • V20147 (3/14)
  • V20148 (3/14)
  • V20152 (4/14)
  • V20154 (4/14)
  • V20155 (4/14)
  • V20180 (4/14)
  • V20181 (4/14)
  • V20182 (4/14)

Distribution

Distributed nationwide across the United States.

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