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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 III June 27, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's… Failed Impurities/Degradation Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II June 27, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL… Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc Terminated
Class II June 27, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL… Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc Terminated
Class II June 27, 2018 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL… Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc Terminated
Class III June 27, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90… Failed Impurities/Degradation Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II June 27, 2018 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC… Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc Terminated
Class II June 27, 2018 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL… Lack of assurance of sterility: Bags have potential to leak. ICU Medical Inc Terminated
Class II June 20, 2018 RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL),… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class II June 20, 2018 Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class III June 20, 2018 Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count… Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification. Mylan Pharmaceuticals Inc. Terminated
Class II June 20, 2018 Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class II June 20, 2018 Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and… CGMP Deviations: Products not manufactured under current good manufacturing practices. BioDiagnostic International Terminated
Class II June 20, 2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle,… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL)… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak,… Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic… Inopak Ltd Terminated
Class II June 20, 2018 Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube,… CGMP Deviations: products may be contaminated with bacteria. Shadow Holdings DBA Bocchi Labs Terminated
Class II June 20, 2018 Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin,… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL… Superpotent and Subpotent PharMEDium Services, LLC Terminated
Class II June 20, 2018 Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave… CGMP Deviations: products may be contaminated with bacteria. Shadow Holdings DBA Bocchi Labs Terminated
Class II June 20, 2018 Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547… CGMP Deviations: products may be contaminated with bacteria. Shadow Holdings DBA Bocchi Labs Terminated
Class II June 20, 2018 Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class II June 20, 2018 Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube,… CGMP Deviations: products may be contaminated with bacteria. Shadow Holdings DBA Bocchi Labs Terminated
Class II June 20, 2018 RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz.,… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class II June 20, 2018 Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL)… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class II June 20, 2018 Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops,… MBi Distributing Inc. dba MBi Nutraceuticals Terminated
Class II June 20, 2018 SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water… RIJ Pharmaceutical LLC Terminated
Class II June 20, 2018 READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count… Microbial Contamination of a Non-Sterile Product. Medline Industries Inc (Northpoint Services) Terminated
Class I June 20, 2018 Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample -… Contraceptive Tablets Out of Sequence. Allergan, PLC. Terminated
Class I June 13, 2018 Naloxone Hydrochloride Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use… Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. HOSPIRA INC, LAKE FOREST Terminated
Class III June 13, 2018 NYSTATIN Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged… Resuspension problems: Out of specification for appearance and resuspendability. Pharmaceutical Associates Inc Terminated
Class III June 13, 2018 Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics… Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II June 13, 2018 Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered… Presence of foreign substance: glass particles Apotex Inc. Terminated
Class I June 6, 2018 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co.… Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The… Shoreside Enterprises Inc. Terminated
Class I June 6, 2018 POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes,… Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The… Shoreside Enterprises Inc. Terminated
Class III June 6, 2018 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx… Labeling: Missing Label LUPIN SOMERSET Terminated
Class I May 30, 2018 Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA… Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of… AMA Wholesale Terminated
Class II May 30, 2018 screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC… CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. Ideaz Llc Terminated
Class II May 30, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured… GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II May 30, 2018 My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two… Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to… Lupin Pharmaceuticals Inc. Terminated
Class II May 30, 2018 Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 CGMP Deviations Mylan Pharmaceuticals Inc. Terminated
Class III May 30, 2018 T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz.… Subpotent Milbar Laboratories, Inc. Terminated
Class II May 30, 2018 screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC… CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. Ideaz Llc Terminated
Class II May 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count… CGMP Deviations Mylan Pharmaceuticals Inc. Terminated
Class II May 30, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured… GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II May 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count… CGMP Deviations Mylan Pharmaceuticals Inc. Terminated
Class II May 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count… CGMP Deviations Mylan Pharmaceuticals Inc. Terminated
Class III May 30, 2018 Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic… Subpotent Milbar Laboratories, Inc. Terminated
Class II May 30, 2018 My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two… Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to… Lupin Pharmaceuticals Inc. Terminated
Class II May 30, 2018 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North… Lack of Assurance of Sterility Fresenius Medical Care Renal Therapies Group, LLC Terminated
Class II May 30, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle,… Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium… Exela Pharma Sciences LLC Terminated
Class II May 30, 2018 Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 CGMP Deviations Mylan Pharmaceuticals Inc. Terminated
Class III May 30, 2018 Lidocaine Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30… Failed Stability Specifications Teva Pharmaceuticals USA Terminated
Class II May 23, 2018 B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic… Microbial Contamination of Non-sterile Product Milbar Laboratories, Inc. Terminated
Class II May 23, 2018 Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc.,… Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs… Prescript Pharmaceuticals, Inc. Terminated
Class II May 23, 2018 Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan… cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to… Mylan Pharmaceuticals Inc. Terminated
Class II May 23, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak… Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs… Prescript Pharmaceuticals, Inc. Terminated
Class II May 23, 2018 Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett… Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs… Prescript Pharmaceuticals, Inc. Terminated
Class II May 23, 2018 Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan… cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according… Mylan Pharmaceuticals Inc. Terminated
Class II May 23, 2018 Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories,… Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs… Prescript Pharmaceuticals, Inc. Terminated
Class III May 23, 2018 Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 Presence of Foreign Tablets/Capsules Aidarex Pharmaceuticals LLC Terminated
Class II May 23, 2018 Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%),… GMP Deviations Milbar Laboratories, Inc. Terminated
Class III May 23, 2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron… Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients… Boiron Inc. Terminated
Class II May 23, 2018 MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional… GMP Deviations Milbar Laboratories, Inc. Terminated
Class II May 23, 2018 Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles,… GMP Deviations Milbar Laboratories, Inc. Terminated
Class I May 23, 2018 Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials… Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency Apotex Inc. Terminated
Class I May 23, 2018 Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials… Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency Apotex Inc. Terminated
Class II May 23, 2018 Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC… Failed Stability Specifications Pharmalucence, Inc. Terminated
Class II May 23, 2018 scopolamine transdermal system Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84);… Defective delivery system L. Perrigo Company Terminated
Class II May 23, 2018 Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx,… Failed Stability Specifications Perrigo New York Terminated
Class III May 23, 2018 Riomet Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic… Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling… Sun Pharmaceutical Industries, Inc. Terminated
Class I May 23, 2018 Piperacillin and Tazobactam Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use… Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass AuroMedics Pharma LLC Terminated
Class II May 23, 2018 Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle,… Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800… Sun Pharmaceutical Industries, Inc. Terminated
Class II May 23, 2018 acetaminophen and codeine phosphate Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak… Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs… Prescript Pharmaceuticals, Inc. Terminated
Class II May 16, 2018 Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and… Lack of Assurance of Sterility Coast Quality Pharmacy LLC Terminated
Class II May 16, 2018 Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy,… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was… Vitalab Pharmacy, Inc Terminated
Class II May 16, 2018 Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Xalkori 250 mg cap NDC 00069-8140-20 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Ibrance 125 mg cap NDC 00069-0189-21 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40… Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Altera Handset NDC 83490-0678-05 56 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was… Vitalab Pharmacy, Inc Terminated
Class II May 16, 2018 Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Botox 100 Units Vial NDC 00023-1145-01 90 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable,… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was… Vitalab Pharmacy, Inc Terminated
Class II May 16, 2018 Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable,… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was… Vitalab Pharmacy, Inc Terminated
Class II May 16, 2018 Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC… Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98 Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30 Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was… Vitalab Pharmacy, Inc Terminated
Class II May 16, 2018 Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape… Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Promacta 50 mg tablet NDC 00078-0686-15 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Temozolomide 20 mg NDC 43975-0253-05 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01 Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was… Vitalab Pharmacy, Inc Terminated
Class II May 16, 2018 Otezla 30 mg tablet NDC 59572-0631-06 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Xolair 150 mg SDV NDC 50242-0040-62 28 days Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Temozolomide 250 mg NDC 43975-0257-05 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04 Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class III May 16, 2018 OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10… Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was… Septodont Inc. Terminated
Class II May 16, 2018 Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. Terminated
Class II May 16, 2018 Metoprolol succinate Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only,… Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count… Dr. Reddy's Laboratories, Inc. Terminated
Class II May 16, 2018 Minivelle Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC… Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties… Noven Pharmaceuticals, Inc. Terminated
Class II May 16, 2018 Minivelle Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC… Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties… Noven Pharmaceuticals, Inc. Terminated
Class I May 16, 2018 Ampicillin and Sulbactam Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or… Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 Docetaxel Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business… Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed. Sanofi-Aventis U.S. LLC Terminated
Class II May 9, 2018 LEVETIRACETAM Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 LEVETIRACETAM Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 LEVETIRACETAM Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 Levofloxacin Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5%… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 Levofloxacin Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5%… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 Levofloxacin Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5%… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class II May 9, 2018 Linezolid Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only,… Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and… AuroMedics Pharma LLC Terminated
Class III May 9, 2018 Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count… Failed Dissolution Specification: Low dissolution outside of specifications Rhodes Pharmaceuticals, L.P. Terminated
Class II May 2, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 LIPO-DEN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased… Premier Pharmacy Labs Inc Terminated
Class II May 2, 2018 Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased… Premier Pharmacy Labs Inc Terminated
Class II May 2, 2018 METHYLCOBALAMIN Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 LIPO-PLEX Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 ADENO-PLEX Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi,… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased… Premier Pharmacy Labs Inc Terminated
Class II May 2, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 LIPO-DEN EXTREME Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 LIPO-DEN PLUS Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi,… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased… Premier Pharmacy Labs Inc Terminated
Class I May 2, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC)… Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on… Bayer HealthCare Pharmaceuticals, Inc. Terminated
Class III May 2, 2018 Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count… Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Mckesson Packaging Services Terminated
Class II May 2, 2018 PYRIDOXINE Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS… Presence of Particulate matter. Recall due to presence of unknown particulate matter. Coastal Meds, LLC. Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 fluocinolone acetonide Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by:… Subpotent Drug Lyne Laboratories, Inc. Terminated
Class II May 2, 2018 fluocinolone acetonide Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only,… Subpotent Drug Lyne Laboratories, Inc. Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class III May 2, 2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By:… Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Mckesson Packaging Services Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 fluocinolone acetonide Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only,… Subpotent Drug Lyne Laboratories, Inc. Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC-… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class III May 2, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By:… Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Mckesson Packaging Services Terminated
Class II May 2, 2018 Ibuprofen Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Time-Cap Laboratories, Inc. Terminated
Class II April 25, 2018 Testosterone Propionate 100mg/mL, 5 mL 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 Estradiol 55 mg (SD) pellets in 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/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell… 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 Estradiol 25 mg (SD) pellets in 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 Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835… 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 Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50… 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 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell… 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 Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, 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 Estradiol 20 mg (SD) pellets in 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 55 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 Estradiol 50 mg (SD) pellets in 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 50 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 Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only,… 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/Estradiol 60 mg/6 mg pellet 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 CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern… 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 B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only,… 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/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell… 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 Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835… 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 Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and… 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 TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835… 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 25 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 ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count… CGMP Deviations: finished products were manufactured with poor quality water. Diamond Wipes International, Inc. Terminated
Class II April 25, 2018 Testosterone 100 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 Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 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 II April 25, 2018 Testosterone Cypionate 200mg/mL, 5 mL 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 WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by… CGMP Deviations: finished products were manufactured with poor quality water. Diamond Wipes International, Inc. Terminated
Class II April 25, 2018 Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL 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 Estradiol 40 mg (SD) pellets in 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 Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835… 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/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell… 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 TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835… 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 Pregnenolone 100 mg (SD) 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 II April 25, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2… Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride… Renaissance Lakewood, LLC Terminated
Class II April 25, 2018 Lipoic Acid 25mg/mL, 5 mL 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 Biotin Suspension 10mg/mL, 5 mL 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 PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube,… Microbial Contamination of Non-Sterile Products Marcas Usa Llc Terminated
Class II April 25, 2018 Testosterone 37.5 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 Testosterone 200 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 III April 25, 2018 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx… Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron,… Sandoz Incorporated Terminated
Class II April 25, 2018 Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell… 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 HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL 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 Estradiol 35 mg (SD) pellets in 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 Estradiol 10 mg (SD) pellets in 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 TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835… 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 MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/… 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 Estradiol 15 mg (SD) pellets in 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 80 mg/8 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 TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL 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 Testosterone 80 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