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.
What this means for you
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
- 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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