Class II
Terminated
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 12, 2014
- Posted
- May 7, 2014
- Recall Number
- D-1280-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 257904 bottles
- Firm Location
- Horsham, PA, United States
Reason for Recall
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15
More recalls by Teva Pharmaceuticals Usa
ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carto...
Sep 2, 2015 · Class I
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfa...
Aug 12, 2015 · Class II
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50...
Jul 15, 2015 · Class I
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026