FDA Drug Recalls in 2017
1,073 recalls found
August 2017
Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
Failed impurities/degradation specifications: Out of specification for a related compound C.
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033200.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
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.
Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076
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.
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
Crystallization with subpotent out of specification assay results for chlorhexidine.
Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
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.
Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
Crystallization with subpotent out of specification assay results for chlorhexidine.
Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202
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.
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
Lack of Sterility Assurance.
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-134-18
Lack of Sterility Assurance.
Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
Lack of Sterility Assurance.
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Lack of Sterility Assurance.
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
Lack of Sterility Assurance.
Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-236-03
Lack of Sterility Assurance.
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
Lack of Sterility Assurance.
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
Lack of Sterility Assurance.
Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15
Lack of Sterility Assurance.
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Presence of Foreign Substance: potential presence of plastic particles.
Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
Lack of Sterility Assurance.
Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222
Lack of Sterility Assurance.
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Lack of Sterility Assurance.
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
Presence of Particulate Matter: Silicone oil
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
Lack of Sterility Assurance.
Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-064-15
Lack of Sterility Assurance.
Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-046-15
Lack of Sterility Assurance.
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Lack of Sterility Assurance.
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.
Presence of Particulate Matter: Silicone oil
Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Lack of Sterility Assurance.
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01
Presence of Particulate Matter: Silicone oil
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Lack of Sterility Assurance.
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg