NoticeMedications
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
NoticeMedications
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
NoticeMedications
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Appco Pharma LLC
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
NoticeMedications
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt
Amneal Pharmaceuticals, LLC
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
NoticeMedications
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags
Amneal Pharmaceuticals, LLC
Product mix up: An IV bag, contained within a labeled Magnesium Sulfate in Water for Injection, 4 g/100 mL foil pouch, was identified as Tranexamic Acid
NoticeMedications
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manu
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
NoticeMedications
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manu
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
NoticeMedications
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manu
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
NoticeMedications
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 275
Chiesi USA, Inc.
Lack of Assurance of Sterility
NoticeMedications
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( N
Amerisource Health Services LLC
Failed tablet specifications.
NoticeMedications
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
NoticeMedications
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f
Apotex Corp.
Lack of Assurance of Sterility
NoticeMedications
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceutic
Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
NoticeMedications
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEAD
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Dro
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industria
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 m
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROU
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bot
K.C. Pharmaceuticals, Inc
Lack of Assurance of Sterility
NoticeMedications
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceutica
STRIDES PHARMA INC
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
NoticeMedications
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Wa
Cardinal Health 200, LLC
Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups.
NoticeMedications
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061,
New Life Pharma LLC
Lack of Assurance of Sterility
NoticeMedications
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Pri
MACLEODS PHARMA USA, INC
Subpotent Drug
NoticeMedications
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, N
New Life Pharma LLC
Lack of Assurance of Sterility
NoticeMedications
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 8
New Life Pharma LLC
Lack of Assurance of Sterility
NoticeMedications
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, N
New Life Pharma LLC
Lack of Assurance of Sterility
NoticeMedications
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My
MYLAN PHARMACEUTICALS INC
Failed Dissolution Specifications
Voluntary RecallMedications
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphat
Radnostix
Failed Tablet/Capsule Specifications
Voluntary RecallMedications
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Ma
Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
NoticeMedications
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Po
HTO Nevada Inc. dba Kirkman
Stability Data Does Not Support Expiry Date.
NoticeMedications
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source,
HTO Nevada Inc. dba Kirkman
Stability Data Does Not Support Expiry Date.
NoticeMedications
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
HTO Nevada Inc. dba Kirkman
Stability Data Does Not Support Expiry Date.
Voluntary RecallMedications
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence
Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
NoticeMedications
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Maj
The Harvard Drug Group LLC
Defective container; inadequately sealed blister packaging.
NoticeMedications
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 843
Harbin Jixianglong Biotech Co., Ltd.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
NoticeMedications
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38
AvKARE
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
NoticeMedications
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 8438
Harbin Jixianglong Biotech Co., Ltd.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Voluntary RecallMedications
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous U
Slate Run Pharmaceuticals
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
NoticeMedications
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC
LEO PHARMA INC
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
NoticeMedications
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals,
Meitheal Pharmaceuticals, Inc
Defective Delivery System: Missing or duplicated needles within the injection kit
NoticeMedications
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road,
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
NoticeMedications
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
NoticeMedications
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 D
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
NoticeMedications
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan R
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
NoticeMedications
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Ba
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
NoticeMedications
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufac
SOMERSET THERAPEUTICS LLC
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Voluntary RecallMedications
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141
Annora Pharma Private Limited
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
NoticeMedications
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tatto
Pro Numb Tattoo Numbing Spray LLC
cGMP deviations