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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 881–900 of 1,000 recalls

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 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 →

Class IIITerminated

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.

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 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.

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 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.

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

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

Akorn Inc

Crystallization with subpotent out of specification assay results for chlorhexidine.

July 12, 2017 · DrugView details →

Class IIITerminated

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.

Akorn Inc

Crystallization with subpotent out of specification assay results for chlorhexidine.

July 12, 2017 · DrugView details →

Class IIITerminated

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

Akorn Inc

Crystallization with subpotent out of specification assay results for chlorhexidine.

July 12, 2017 · DrugView details →

Class IIITerminated

Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.

Pfizer Inc.

CGMP Deviations: Firm failed to control impurity for color change at the API stage.

July 12, 2017 · DrugView details →

Class IIITerminated

Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

July 11, 2017 · DrugView details →

Class IIITerminated

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

Hospira Inc., A Pfizer Company

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

July 6, 2017 · DrugView details →

Class IIITerminated

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

June 29, 2017 · DrugView details →

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