August 30, 2017DrugsFDA
C. O. Truxton recalls Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown,
Hazard: Labeling: Label Mixup; potentially mislabeled
August 30, 2017DrugsFDA
C. O. Truxton recalls Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown,
Hazard: Labeling: Label Mixup; potentially mislabeled
August 30, 2017DrugsFDA
C. O. Truxton recalls Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown,
Hazard: Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany,
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germa
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany,
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany,
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germ
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in G
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in German
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germa
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Ger
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germ
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle,
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 2
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Linde Eckstein Gmbh + Co KG recalls Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net.
Hazard: Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
August 23, 2017DrugsFDA
Global Marketing Enterprises, Inc. recalls Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLi
Hazard: Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
August 23, 2017DrugsFDA
Hetero USA Inc recalls Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,
Hazard: Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
August 23, 2017DrugsFDA
AVKARE Inc. recalls Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38
Hazard: Failed impurities/degradation specifications: Out of specification for a related compound C.
August 23, 2017DrugsFDA
Lupin Limited (Unit 1) recalls Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wa
Hazard: Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
August 23, 2017DrugsFDA
Genetic Edge Compounds LLC recalls GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 70058049
Hazard: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
August 23, 2017DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA
Hazard: Presence of Particulate Matter; stainless steel
August 23, 2017DrugsFDA
Akorn Inc recalls Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufacture
Hazard: Crystallization with subpotent out of specification assay results for chlorhexidine.
August 23, 2017DrugsFDA
Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufacture
Hazard: Crystallization with subpotent out of specification assay results for chlorhexidine.
August 23, 2017DrugsFDA
Akorn Inc recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (
Hazard: Crystallization with subpotent out of specification assay results for chlorhexidine.
August 23, 2017DrugsFDA
DYNAMIC TECHNICAL FORMULATIONS recalls Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 1
Hazard: Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
August 23, 2017DrugsFDA
Amgen, Inc. recalls Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by
Hazard: Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
August 23, 2017DrugsFDA
HARDCORE FORMULATIONS recalls D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
Hazard: Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
August 23, 2017DrugsFDA
HARDCORE FORMULATIONS recalls ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
Hazard: Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.