March 29, 2023DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) b
Hazard: Labeling: Label Mix-up
March 22, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine
Hazard: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
March 22, 2023DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 167
Hazard: Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
March 22, 2023DrugsFDA
AVEVA Drug Delivery Systems, Inc. recalls Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manu
Hazard: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
March 22, 2023DrugsFDA
AVEVA Drug Delivery Systems, Inc. recalls Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manu
Hazard: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
March 22, 2023DrugsFDA
Padagis US LLC recalls Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Onl
Hazard: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
March 22, 2023DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA,
Hazard: CGMP Deviations: Potential risk of Cross Contamination
March 22, 2023DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA,
Hazard: CGMP Deviations: Potential risk of Cross Contamination
March 22, 2023DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 519
Hazard: CGMP Deviations: Potential risk of Cross Contamination
March 22, 2023DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991
Hazard: CGMP Deviations: Potential risk of Cross Contamination
March 22, 2023DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 5199
Hazard: CGMP Deviations: Potential risk of Cross Contamination
March 22, 2023DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1
Hazard: CGMP Deviations: Potential risk of Cross Contamination
March 15, 2023DrugsFDA
Pharmedica USA, LLC recalls Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix,
Hazard: CGMP Deviations
March 15, 2023DrugsFDA
Pharmedica USA, LLC recalls Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bott
Hazard: Non-Sterility
March 15, 2023DrugsFDA
Nanomaterials Discovery Corporation recalls Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distribu
Hazard: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
March 15, 2023DrugsFDA
Akron Pharma, Inc. recalls DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-282
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Ox
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g)
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 068
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Ecometics, Inc. recalls Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottle
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 137
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compa
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, ND
Hazard: CGMP DEVIATIONS
March 15, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratori
Hazard: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
March 15, 2023DrugsFDA
Nutraceutical Corporation recalls NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nu
Hazard: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
March 15, 2023DrugsFDA
Nutraceutical Corporation recalls NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceuti
Hazard: CGMP Deviations: Raw material recalled by repackager, due to discoloration.