Class IIFDA
Pharmatech LLC recalls Rugby Liquid Vitamin C Supplement 500 mg 118 mL UPC 00536-0160-97 (Class II)
Presence of yeast and potential contamination with B. cepacia.
Class IIFDAF-0254-2017
Pharmatech LLC recalls Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement. (Class II)
Class II — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.
Product
Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.; Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.; Calcionate Syrup, Calcium Glubionate Syrup, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.; D3 Vitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.; Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.; Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.; Fer-Iron Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.; Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.; Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.; Tri-Vitamin, 50 mL, OTC Non-Sterile. Dietary supplement.; Liquid Vitamin C, 4 oz./118 mL, OTC Non-Sterile. Dietary supplement.; CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.; Poly-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Poly-Vita Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.; D-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Ferrous Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Tri-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Pedia Tri-Vite Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.; Pedia Poly-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Pedia D-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.; Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.; CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
- Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
- Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
- Calcionate Syrup, Calcium Glubionate Syrup, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
- D3 Vitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
- Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.
- Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
- Fer-Iron Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
- Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
- Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
- Tri-Vitamin, 50 mL, OTC Non-Sterile. Dietary supplement.
- Liquid Vitamin C, 4 oz./118 mL, OTC Non-Sterile. Dietary supplement.
- CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.
- Poly-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Poly-Vita Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
- D-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Ferrous Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Tri-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Pedia Tri-Vite Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
- Pedia Poly-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Pedia D-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
- CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
Reason for recall
Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.
Affected products (23)
| Recall # | Product | Lot / code | Status |
|---|---|---|---|
| F-0254-2017 | Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 69543-367-16; Lot No. 28601502, Exp. Date 11/2017; Lot No. 28601601, Exp. Date 01/2018; Lot No. 28601602, Exp. Date 03/2018; Lot No. 28601603, Exp. Date 06/2018; Lot No. 28601604, Exp. Date 06/2018. | Terminated |
| F-0255-2017 | Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 69543-262-16; Lot No. 28891502, Exp. Date 12/2017; Lot No. 28891503, Exp. Date 12/2017. | Terminated |
| F-0256-2017 | Calcionate Syrup, Calcium Glubionate Syrup, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005362770851, Exp. Date 06/2018. | Terminated |
| F-0257-2017 | D3 Vitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005368400806; Lot No. 20691509, Exp. Date11/2017; Lot No. 20691601, Exp. Date 01/2018; Lot No. 20691602, Exp. Date 02/2018; Lot No. 20691604, Exp. Date 05/2018. | Terminated |
| F-0258-2017 | Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005362790590; Lot No. 20471516, 20471517, 20471518, 20471519, & 20471520, Exp. Date 11/2017; Lot No. 20471521, Exp. Date 12/2017; Lot No. 20471601, Exp. Date 01/2018; Lot No. 20471608, Exp. Date 04/2018; Lot No. 20471610 & 20471613, Exp. Date 05/2018; Lot No. 20471614, Exp. Date 06/2018. | Terminated |
| F-0259-2017 | Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005360650858; Lot No. 22461511 & 22461512, Exp. Date 10/2017; Lot No. 22461513 & 22461514, Exp. Date 11/2017; Lot No. 22461515 & 22461516, Exp. Date 12/2017; Lot No. 22461601 & 22461602, Exp. Date 02/2018; Lot No. 22461603 & 22461604, Exp. Date 04/2018; Lot No. 22461605 & 22461606, Exp. Date 05/2018. | Terminated |
| F-0260-2017 | Fer-Iron Liquid, 50 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005360710804; Lot No. 20901507, Exp. Date 07/2017; Lot No. 20901507, Exp. Date 11/2017; Lot No. 20901603, Exp. Date 05/2018 | Terminated |
| F-0261-2017 | Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005360710801; Lot No. 21021510, Exp. Date 07/2017; Lot No. 21021601, Exp. Date 01/2018; Lot No. 21021602, Exp. Date 02/2018; Lot No. 21021604, Exp. Date 05/2016. | Terminated |
| F-0262-2017 | Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005368450801; Lot No. 20701511, Exp. Date 09/2018; Lot No. 20701514, Exp. Date 12/2017; Lot No. 20701605, Exp. Date 05/2018; Lot No. 20701606, Exp. Date 06/2018. | Terminated |
| F-0263-2017 | Tri-Vitamin, 50 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005368501800; Lot No. 20731506, Exp. Date 08/2017; Lot No. 20731603, Exp. Date 02/2018; Lot No. 20731604, Exp. Date 06/2018. | Terminated |
| F-0264-2017 | Liquid Vitamin C, 4 oz./118 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 005360160975; Lot No. 20331510 & 20331511, Exp. Date 12/2017; Lot No. 20331601 & 20331602, Exp. Date 03/2018. | Terminated |
| F-0265-2017 | CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 0904-5023-09; Lot No. 20471602, Exp. Date 01/2018; Lot No. 20471603 & 20471604, Exp. Date 02/2018; Lot No. 20471605 & 20171606, Exp. Date 03/2018; Lot No. 20471607, Exp. Date 04/2018; Lot No. 20471609, 20471611& 20471612, Exp. Date 05/2018. | Terminated |
| F-0266-2017 | Poly-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 0904-5099-50; Lot No. 20701509 & 20701511, Exp. Date 09/2017; Lot No. 20701513, Exp. Date 12/2017; Lot No. 20701601, Exp. Date 02/2018; Lot No. 20701602 & 20701603, Exp. Date 04/2018; Lot No. 20701606, Exp. Date 06/2016. | Terminated |
| F-0267-2017 | Poly-Vita Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 0904-5100-50; Lot No. 21021510, Exp. Date 07/2017; Lot No. 21021601, Exp. Date 01/2018; Lot No. 21021602, Exp. Date 02/2016; Lot No. 21021603, Exp. Date 04/2018; Lot No. 21021604, Exp. Date 05/2018. | Terminated |
| F-0268-2017 | D-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 0904-6273-50; Lot No. 20691509, Exp. Date 11/2017; Lot No. 20691510, Exp. Date 12/2017; Lot No. 206916603, Exp. Date 03/2018; Lot No. 20691605, Exp. Date 04/2018. | Terminated |
| F-0269-2017 | Ferrous Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 0904-6060-50; Lot No. 20901509 & 20901510, Exp. Date 11/2017; Lot No. 20901601, Exp. Date 02/2018; Lot No. 20901602, Exp. Date 03/2018; Lot No. 20901603, Exp. Date 05/2018. | Terminated |
| F-0270-2017 | Tri-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 0904-6274-50; Lot No. 20731506, Exp. Date 08/20107; Lot No. 20731507, Exp. Date 11/2017; Lot No. 20731604 & 20731605, Exp. Date 06/2018. | Terminated |
| F-0271-2017 | Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 76518-020-50, Lot No. 20731506, Exp. Date 08/2017; Lot No. 20731508, Exp. Date 11/2017. | Terminated |
| F-0272-2017 | Pedia Tri-Vite Drops with Iron, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 76518-040-50, Lot No. 21021511, Exp. Date 11/2017. | Terminated |
| F-0273-2017 | Pedia Poly-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 76518-030-50; Lot No. 20701512, Exp. Date 11/2017. | Terminated |
| F-0274-2017 | Pedia D-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement. | NDC No. 76518-050-50; Lot No. 20691509, Exp. Date 11/2017 | Terminated |
| F-0275-2017 | Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement. | Lot No. 30161601, Exp. Date 01/2018; Lot No. 30161602 & 30161603. | Terminated |
| F-0276-2017 | CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement. | UPC No. 632687615989; Lot No. 30661601, Exp. Date 05/2018. | Terminated |
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