Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22
eVenus Pharmaceutical Laboratories
Class I - Dangerous
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01
Acella Pharmaceuticals
Class I - Dangerous
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I - Dangerous
Out-of-specification organic impurity results obtained during routine stability testing.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.
Genesis Partnership Company SA
Class I - Dangerous
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.
Genesis Partnership Company SA
Class I - Dangerous
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Class I - Dangerous
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427.
Genesis Partnership Company SA
Class I - Dangerous
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.
Genesis Partnership Company SA
Class I - Dangerous
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Class I - Dangerous
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
Calvin Scott & Company
Class I - Dangerous
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
Calvin Scott & Company
Class I - Dangerous
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
Calvin Scott & Company
Class I - Dangerous
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
PAI Holdings, LLC.
Class I - Dangerous
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint