Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0759-2018 | 04-03-2018 | Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0748-2018 | 04-03-2018 | Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0779-2018 | 04-03-2018 | Xalkori 250 mg cap NDC 00069-8140-20 30 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0797-2018 | 04-03-2018 | Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0763-2018 | 04-03-2018 | Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0778-2018 | 04-03-2018 | Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply | Lack of Processing Controls. | Kroger Specialty Pharmacy, Inc. / Unknown | Class II | Terminated |
| D-0629-2018 | 04-02-2018 | ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0. | CGMP Deviations: finished products were manufactured with poor quality water. | Diamond Wipes International, Inc. / 51,840 pouches | Class II | Terminated |
| D-0630-2018 | 04-02-2018 | WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6. | CGMP Deviations: finished products were manufactured with poor quality water. | Diamond Wipes International, Inc. / 5,148,792 pouches | Class II | Terminated |
| D-0628-2018 | 03-30-2018 | PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60 | Microbial Contamination of Non-Sterile Products | Marcas Usa Llc / 69,238 60 oz. tubes | Class II | Terminated |
| D-0633-2018 | 03-30-2018 | Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15 Package NDCs: 50268-069-11; 50268-069-15 | Failed Dissolution Specifications | AVKARE Inc. / 2135 cartons | Class II | Terminated |
| D-0624-2018 | 03-29-2018 | Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02 | CGMP Deviations: the product was produced with substandard GMP manufacturing processes. | United Pacific Co Ltd / 15,190 boxes | Class II | Terminated |
| D-0611-2018 | 03-29-2018 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. | Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. | Akorn, Inc. / 56,1800 unit dose cups | Class III | Terminated |
| D-0612-2018 | 03-29-2018 | 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97012. | Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. | Akorn, Inc. / 48,176 unit dose cups | Class III | Terminated |
| D-0613-2018 | 03-29-2018 | 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014. | Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay. | Akorn, Inc. / 20,587 unit dose cups | Class III | Terminated |
| D-0621-2018 | 03-28-2018 | Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06 | cGMP Deviations | Elroselabs Inc. / Unknown | Class II | Terminated |
| D-0622-2018 | 03-28-2018 | Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. | cGMP Deviations | Elroselabs Inc. / Unknown | Class II | Terminated |
| D-0623-2018 | 03-28-2018 | Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL | cGMP Deviations | Elroselabs Inc. / Unknown | Class II | Terminated |
| D-0684-2018 | 03-27-2018 | Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Superpotent Drug | Lupin Pharmaceuticals Inc. / 40,824 bottles | Class II | Terminated |
| D-0703-2018 | 03-27-2018 | Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51 Package NDCs: 55150-242-51 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 395150 bags | Class II | Terminated |
| D-0705-2018 | 03-27-2018 | Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47. Package NDCs: 55150-246-47; 55150-247-47; 55150-248-47 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 261250 bags | Class II | Terminated |
| D-0706-2018 | 03-27-2018 | Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47. Package NDCs: 55150-246-47; 55150-247-47; 55150-248-47 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 188941 bags | Class II | Terminated |
| D-0707-2018 | 03-27-2018 | Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47. Package NDCs: 55150-246-47; 55150-247-47; 55150-248-47 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 67300 bags | Class II | Terminated |
| D-0704-2018 | 03-27-2018 | Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46. Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 46824 bags | Class II | Terminated |
| D-0708-2018 | 03-27-2018 | Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47 Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 308472 bags | Class II | Terminated |
| D-0709-2018 | 03-27-2018 | Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52 Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap | AuroMedics Pharma LLC / 308112 bags | Class II | Terminated |
| D-0643-2018 | 03-22-2018 | Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 2 vials | Class II | Terminated |
| D-0655-2018 | 03-22-2018 | Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0677-2018 | 03-22-2018 | Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0676-2018 | 03-22-2018 | Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0680-2018 | 03-22-2018 | Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0668-2018 | 03-22-2018 | Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0647-2018 | 03-22-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 1 vial | Class II | Terminated |
| D-0646-2018 | 03-22-2018 | Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 4 vials | Class II | Terminated |
| D-0667-2018 | 03-22-2018 | Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0654-2018 | 03-22-2018 | Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / one vial | Class II | Terminated |
| D-0652-2018 | 03-22-2018 | Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 1 vial | Class II | Terminated |
| D-0637-2018 | 03-22-2018 | CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 3 vials | Class II | Terminated |
| D-0635-2018 | 03-22-2018 | B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 5 vials | Class II | Terminated |
| D-0642-2018 | 03-22-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0650-2018 | 03-22-2018 | Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper, | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / five vials | Class II | Terminated |
| D-0671-2018 | 03-22-2018 | Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0657-2018 | 03-22-2018 | Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0681-2018 | 03-22-2018 | Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0672-2018 | 03-22-2018 | Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0634-2018 | 03-22-2018 | Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 4 vials | Class II | Terminated |
| D-0679-2018 | 03-22-2018 | Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0640-2018 | 03-22-2018 | Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0674-2018 | 03-22-2018 | Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0670-2018 | 03-22-2018 | Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0659-2018 | 03-22-2018 | TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0649-2018 | 03-22-2018 | Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / one vial | Class II | Terminated |
| D-0665-2018 | 03-22-2018 | Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0678-2018 | 03-22-2018 | Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0636-2018 | 03-22-2018 | Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 2 vials | Class II | Terminated |
| D-0662-2018 | 03-22-2018 | Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0661-2018 | 03-22-2018 | TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0673-2018 | 03-22-2018 | Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0651-2018 | 03-22-2018 | Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0639-2018 | 03-22-2018 | HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / four vials | Class II | Terminated |
| D-0664-2018 | 03-22-2018 | Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0658-2018 | 03-22-2018 | TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0644-2018 | 03-22-2018 | Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 7 vials | Class II | Terminated |
| D-0641-2018 | 03-22-2018 | Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 11 vials | Class II | Terminated |
| D-0663-2018 | 03-22-2018 | Testosterone 100 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0656-2018 | 03-22-2018 | MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0675-2018 | 03-22-2018 | Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0682-2018 | 03-22-2018 | Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800. | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0660-2018 | 03-22-2018 | TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0638-2018 | 03-22-2018 | Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / four vials | Class II | Terminated |
| D-0669-2018 | 03-22-2018 | Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0653-2018 | 03-22-2018 | Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 7 vials | Class II | Terminated |
| D-0666-2018 | 03-22-2018 | Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0648-2018 | 03-22-2018 | Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / | Class II | Terminated |
| D-0645-2018 | 03-22-2018 | TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. | Partell Specialty Pharmacy / 15 vials | Class II | Terminated |
| D-0616-2018 | 03-21-2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10. Package NDCs: 51862-295-50; 51862-295-10 | Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. | Mayne Pharma Inc / 3312 cans | Class III | Terminated |
| D-0606-2018 | 03-19-2018 | Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01. Package NDCs: 68462-406-01; 68462-406-10; 68462-302-01; 68462-302-05 | Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day. | Glenmark Pharmaceuticals Inc., USA / 109,080 Bottles | Class III | Terminated |
| D-0620-2018 | 03-19-2018 | Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454. Package NDCs: 0093-3223-08; 0093-3223-19; 0093-3223-97 | Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator. | Teva Pharmaceuticals USA / 640,486 vaginal inserts | Class II | Terminated |
| D-0626-2018 | 03-19-2018 | Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01 | Labeling: Incorrect or Missing Lot and/or Exp Date | Lake Erie Medical & Surgical Supply Inc / 16 paper cartons | Class III | Terminated |
| D-0618-2018 | 03-15-2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03 Package NDCs: 69097-877-02; 69097-877-03; 69097-877-07; 69097-877-12; 69097-878-02; 69097-878-03; 69097-878-07; 69097-878-12; 69097-879-02; 69097-879-03; 69097-879-07; 69097-879-12 | Failed Dissolution Specifications; during stability testing | InvaGen Pharmaceuticals, Inc. / N/A | Class III | Terminated |
| D-0619-2018 | 03-15-2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Package NDCs: 69097-877-02; 69097-877-03; 69097-877-07; 69097-877-12; 69097-878-02; 69097-878-03; 69097-878-07; 69097-878-12; 69097-879-02; 69097-879-03; 69097-879-07; 69097-879-12 | Failed Dissolution Specifications; during stability testing | InvaGen Pharmaceuticals, Inc. / N/A | Class III | Terminated |
| D-0697-2018 | 03-15-2018 | All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall. | Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton. | Bayer HealthCare Pharmaceuticals, Inc. / 188,631 units | Class I | Terminated |
| D-0617-2018 | 03-09-2018 | Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Akorn, Inc. / 4,128 bottles | Class III | Terminated |
| D-0589-2018 | 03-09-2018 | Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4. | Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period. | Alva-Amco Pharmacal Companies., Inc. / 206,513 tubes | Class III | Terminated |
| D-0625-2018 | 03-08-2018 | Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021 | Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction. | Jimmy Weber / 315 capsules | Class I | Terminated |
| D-0598-2018 | 03-08-2018 | Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90 | Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing. | Dr. Reddy's Laboratories, Inc. / 4,152 tubes | Class III | Terminated |
| D-0609-2018 | 03-08-2018 | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01 Package NDCs: 32909-770-01 | Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot. | Bracco Diagnostics Inc. / 2,136 tubes | Class II | Terminated |
| D-0591-2018 | 03-07-2018 | 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 / 21 g | Class II | Terminated |
| D-0614-2018 | 03-07-2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 144 bags | Class II | Terminated |
| D-0592-2018 | 03-07-2018 | Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients | Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. | American Pharmaceutical Ingredients LLC / 1460 GM | Class II | Terminated |
| D-0615-2018 | 03-07-2018 | Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. | Apollo Care / 96 bags | Class II | Terminated |
| D-0588-2018 | 03-05-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Sagent Pharmaceuticals Inc / 48,964 vials | Class II | Terminated |
| D-0587-2018 | 03-05-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Sagent Pharmaceuticals Inc / 176,410 vials | Class II | Terminated |
| D-0586-2018 | 03-05-2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05. | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Sagent Pharmaceuticals Inc / 205,370 vials | Class II | Terminated |
| D-0607-2018 | 03-05-2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01 | Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product. | Pine Pharmaceuticals, LLC / 136 units | Class III | Terminated |
| D-0698-2018 | 03-05-2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37 | Failed impurities/degradation specifications: Failure to water content and impurity | InvaGen Pharmaceuticals, Inc. / 3222 vials | Class III | Terminated |
| D-0599-2018 | 03-05-2018 | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 Package NDCs: 43386-118-03; 43386-118-01; 43386-118-05; 3433861180 | Failed Impurities/Degradation Specifications | Novel Laboratories, Inc. / 134,364 bottles (4,030,920 tablets) | Class III | Terminated |
| D-1077-2019 | 03-05-2018 | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742 | Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API. | Johnson Matthey Inc. / 169.976 kg | Class II | Terminated |
| D-0605-2018 | 03-02-2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10 | Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability | Renaissance Lakewood, LLC / 1277 bags | Class III | Terminated |
| D-0581-2018 | 02-28-2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10 Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30 | Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet. | Osmotica Pharmaceutical Corp / 19,664 100-bottles | Class III | Terminated |
| D-0608-2018 | 02-26-2018 | Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27 Package NDCs: 0574-2067-27; 0574-2067-00 | Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product. | Paddock Laboratories, LLC. / 52,596 bottles | Class II | Terminated |
