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.

FDA recall notice · announced January 29, 2014 · Teva Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: 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).
Quantity: 234,242 bottles
Status: Terminated
Products in this recall event:
- 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. (D-747-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.