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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 10221–10240 of 17,793 recalls

Class IIITerminated

Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: high out of specification results for related compound D.

July 25, 2017 · DrugView details →

Class ITerminated

LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.

EZWeightLossTX LLC

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.

July 24, 2017 · DrugView details →

Class ITerminated

LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.

EZWeightLossTX LLC

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.

July 24, 2017 · DrugView details →

Class IITerminated

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60

Teva Pharmaceuticals USA

Failed Tablet/Capsule Specification; out of specification for tablet weight

July 24, 2017 · DrugView details →

Class ITerminated

Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY

Chiavna Saffron LLC

Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil

July 21, 2017 · DrugView details →

Class IITerminated

Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30

Hetero USA Inc

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

July 20, 2017 · DrugView details →

Class IIITerminated

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

AVKARE Inc.

Failed impurities/degradation specifications: Out of specification for a related compound C.

July 19, 2017 · DrugView details →

Class IITerminated

Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magnesium Citrate, UPC# 308690686383, NDC 0869-686-38, Distributed by: Vi-Jon, Smyrna, TN, 37167 ; d) ShopRite Magnesium Citrate Oral Solution Saline Laxative Low Sodium, UPC# 041190211487, NDC 41190-686-38, Distributed by: Wakefern Food Corporation, Jamesburg, NJ 08831

Vi-Jon, Inc.

Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class ITerminated

New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: bestherbscoffee@yahoo.com

BESTHERBS COFFEE LLC

Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

Class IIITerminated

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.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →

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