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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II April 25, 2018 Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S.… Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Partell Specialty Pharmacy Terminated
Class II April 25, 2018 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty… Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Partell Specialty Pharmacy Terminated
Class II April 25, 2018 Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy,… Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Partell Specialty Pharmacy Terminated
Class II April 25, 2018 Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S.… Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Partell Specialty Pharmacy Terminated
Class III April 25, 2018 Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per… cGMP deviations Pharmedium Services, LLC Terminated
Class II April 25, 2018 TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial,… Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. Partell Specialty Pharmacy Terminated
Class III April 25, 2018 CYSTARAN Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by… Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. LEADIANT BIOSCIENCES, INC Terminated
Class II April 25, 2018 Daytrana Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr)… Defective Delivery System: Out of specification for adhesive transfer. Noven Pharmaceuticals, Inc. Terminated
Class II April 25, 2018 Cefdinir Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC… Superpotent Drug Lupin Pharmaceuticals Inc. Terminated
Class II April 25, 2018 Amantadine HCl Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,… Failed Dissolution Specifications AVKARE Inc. Terminated
Class II April 18, 2018 Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured… cGMP Deviations Elroselabs Inc. Terminated
Class III April 18, 2018 Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care… Labeling: Incorrect or Missing Lot and/or Exp Date Lake Erie Medical & Surgical Supply Inc Terminated
Class II April 18, 2018 Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938… CGMP Deviations: the product was produced with substandard GMP manufacturing processes. United Pacific Co Ltd Terminated
Class II April 18, 2018 Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. cGMP Deviations Elroselabs Inc. Terminated
Class II April 18, 2018 Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs,… cGMP Deviations Elroselabs Inc. Terminated
Class III April 18, 2018 Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa,… Failed impurities/degradation specifications: Failure to water content and impurity InvaGen Pharmaceuticals, Inc. Terminated
Class III April 11, 2018 BUPROPION HYDROCHLORIDE (SR) buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only,… Failed Dissolution Specifications; during stability testing InvaGen Pharmaceuticals, Inc. Terminated
Class III April 11, 2018 BUPROPION HYDROCHLORIDE (SR) buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03)… Failed Dissolution Specifications; during stability testing InvaGen Pharmaceuticals, Inc. Terminated
Class III April 11, 2018 Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma,… Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. Mayne Pharma Inc Terminated
Class II April 4, 2018 Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare,… Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Apollo Care Terminated
Class III April 4, 2018 Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible… Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability Renaissance Lakewood, LLC Terminated
Class I April 4, 2018 Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8… Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved… Jimmy Weber Terminated
Class II April 4, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801… Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Apollo Care Terminated
Class III April 4, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15)… Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. Akorn, Inc. Terminated
Class III April 4, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG… Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. Akorn, Inc. Terminated
Class III April 4, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG… Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. Akorn, Inc. Terminated
Class II April 4, 2018 Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per… Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation… Paddock Laboratories, LLC. Terminated
Class II April 4, 2018 E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by… Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during… Bracco Diagnostics Inc. Terminated
Class II April 4, 2018 Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by:… Presence of particulate matter Amneal Pharmaceuticals Terminated
Class III April 4, 2018 Indomethacin Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark… Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or… Glenmark Pharmaceuticals Inc., USA Terminated
Class III March 28, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine… Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive… Pine Pharmaceuticals, LLC Terminated
Class III March 28, 2018 Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm… Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Akorn, Inc. Terminated
Class II March 28, 2018 Estradiol Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08)… Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the… Teva Pharmaceuticals USA Terminated
Class II March 28, 2018 DELFLEX DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4… Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. Fresenius Medical Care Renal Therapies Group, LLC Terminated
Class II March 21, 2018 Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC… Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. American Pharmaceutical Ingredients LLC Terminated
Class II March 21, 2018 Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3 Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. American Pharmaceutical Ingredients LLC Terminated
Class II March 21, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose… Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Sagent Pharmaceuticals Inc Terminated
Class II March 21, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose… Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Sagent Pharmaceuticals Inc Terminated
Class II March 21, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose… Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Sagent Pharmaceuticals Inc Terminated
Class III March 21, 2018 Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57… Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry… Alva-Amco Pharmacal Companies., Inc. Terminated
Class II March 21, 2018 Valganciclovir Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber… Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher… Hetero Labs Limited Unit V Terminated
Class III March 21, 2018 Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's… Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing. Dr. Reddy's Laboratories, Inc. Terminated
Class II March 21, 2018 Valacyclovir Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber… Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher… Hetero Labs Limited Unit V Terminated
Class I March 21, 2018 HYDROMORPHONE HYDROCHLORIDE Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose… Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. Pfizer Inc. Terminated
Class I March 21, 2018 HYDROMORPHONE HYDROCHLORIDE Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose… Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. Pfizer Inc. Terminated
Class III March 21, 2018 Hydrocodone Bitartrate and Homatropine Methylbromide Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only… Failed Impurities/Degradation Specifications Novel Laboratories, Inc. Terminated
Class II March 14, 2018 Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801… Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Apollo Care Terminated
Class II March 14, 2018 RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal… Failed Stability Specifications Mckesson Packaging Services Terminated
Class III March 14, 2018 labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA… Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date… SCA Pharmaceuticals, LLC. Terminated
Class I March 14, 2018 Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th… Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a… Bella All Natural Terminated
Class II March 14, 2018 Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing,… cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… Kalchem International, Inc. Terminated
Class II March 14, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801… Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Apollo Care Terminated
Class III March 14, 2018 Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra… Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph). AstraZeneca Pharmaceuticals LP Terminated
Class III March 14, 2018 Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only,… Failed Stability Specification: OOS low viscosity results discovered during retain testing. Akorn, Inc. Terminated
Class II March 14, 2018 Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%,… Labeling: Label mix-up Bayer HealthCare Pharmaceuticals, Inc. Terminated
Class III March 14, 2018 Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported… Superpotent drug: failed assay throughout the stick after 6 months stability. Oxygen Development Llc Terminated
Class II March 14, 2018 Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit… CGMP deviations: Ibuprofen is being recalled in response to previous recall Spirit Pharmaceuticals, LLC Terminated
Class III March 14, 2018 Methylphenidate Hydrochloride Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx… Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg… Osmotica Pharmaceutical Corp Terminated
Class II March 14, 2018 Labetalol Hydrochloride Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx… Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. Hospira Inc. A Pfizer Company Terminated
Class II March 7, 2018 SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9),… Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and… Fagron, Inc Terminated
Class I March 7, 2018 GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle,… Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans Kareway Products Inc Terminated
Class II March 7, 2018 INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only,… Failed Stability Specifications: Product stability testing results did not meet specifications for iron content. ALLERGAN Terminated
Class I March 7, 2018 Levofloxacin Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible… Presence of Particulate Matter; contains visible particulate matter identified as mold. AuroMedics Pharma LLC Terminated
Class III March 7, 2018 CYSTARAN Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by… Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. LEADIANT BIOSCIENCES, INC Terminated
Class II March 7, 2018 PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ… Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. Medline Industries Inc Terminated
Class II March 7, 2018 Acyclovir Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11]… Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some… Apace KY LLC Terminated
Class II March 7, 2018 Sodium Chloride 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only,… Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene,… B. Braun Medical Inc Terminated
Class II February 28, 2018 Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Methadone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Labetalol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Glycopyrrolate in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Adenosine Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Succinylcholine Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Esmolol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses,… Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all… Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses,… Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Midazolam HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Ketamine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Fentanyl Citrate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Rocuronium Bromide in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Atropine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all… Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Lidocaine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Nicardipine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses,… Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7);… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b)… CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in… American Pharmaceutical Ingredients LLC Terminated
Class II February 28, 2018 Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class II February 28, 2018 Ropivacaine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Pharmedium Services, LLC Terminated
Class III February 28, 2018 Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by… Presence of Foreign Tablets/Capsules Nostrum Laboratories Inc Terminated
Class III February 28, 2018 Metformin Hydrochloride Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured… Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg Aurobindo Pharma Ltd. Terminated
Class II February 21, 2018 Aripiprazole Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters… CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. AMERICAN HEALTH PACKAGING Terminated
Class II February 21, 2018 Famciclovir Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber… Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a… Hetero Labs Limited Unit V Terminated
Class II February 21, 2018 Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suction Swabs… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class I February 21, 2018 Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count… Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the… Primus Pharmaceuticals, Inc. Terminated
Class II February 21, 2018 Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class I February 21, 2018 HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx… Non-Sterility The Compounding Pharmacy of America Terminated
Class II February 21, 2018 Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector,… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer,… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only,… Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and… PharMEDium Services, LLC Terminated
Class II February 21, 2018 Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Suction Swab System With Antiseptic Oral Rinse and Mouth Moisturizer.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only,… Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and… PharMEDium Services, LLC Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class I February 21, 2018 Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus… Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the… Primus Pharmaceuticals, Inc. Terminated
Class II February 21, 2018 Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Short Term Oral Swab System with Antiseptic Oral Rinse, Contains 20… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow… Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and… PharMEDium Services, LLC Terminated
Class II February 21, 2018 Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class I February 21, 2018 Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic… Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of… Magno Humphries Laboratories, Inc Terminated
Class I February 21, 2018 Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count… Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the… Primus Pharmaceuticals, Inc. Terminated
Class II February 21, 2018 Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 QCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class I February 21, 2018 Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus… Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the… Primus Pharmaceuticals, Inc. Terminated
Class III February 21, 2018 BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL)… CGMP Deviations: not manufactured according to current good manufacturing practices. Webrx dba RxPalace.com Terminated
Class III February 21, 2018 Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology… Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil BYL Solutions Inc. Terminated
Class II February 21, 2018 Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Suction Toothbrush with Antiseptic Oral Rinse. Contains 1 Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer,… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class III February 21, 2018 AZELASTINE HYDROCHLORIDE Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only,… Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the %… Sun Pharmaceutical Industries, Inc. Terminated