Reported Jan 29, 2014 · Terminated

Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva…

Teva Pharmaceuticals USA, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512

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
NDC0093-5414-95

Lot codes and dates: 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)
V20086 (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)
V20203 (5/14)
V20204 (5/14)
V20233 (5/14)
V20234 (5/14)
V20273 (6/14)
V20274 (6/14)
V20275 (6/14)
V20293 (8/14)
V20294 (8/14)
V20321 (9/14)
V20322 (9/14)
V20323 (9/14)
V20324 (9/14)
V20325 (9/14)
V20326 (9/14)
V20327 (9/14)
V20369 (10/14)
V20370 (10/14)
V20410 (11/14)
V20411 (11/14)
V20412 (11/14)
V30009 (12/14)
V30010 (12/14)
V30011 (12/14)
V30056 (01/15)
V30120 (2/15)
V30122 (2/15)
V30123 (2/15)
V30163 (3/15)
V30164 (3/15)
V30165 (3/15)
V30190 (3/15)
V30249 (5/15)
V30250 (5/15)
Amount recalled: 234,242 bottles

Failed Stability Specifications: this product is below specification for preservative content.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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21 in total.