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Drug recalls

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

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II March 22, 2017 HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 4901 Morena Blvd… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), Rx only, Synergy RX,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, Synergy RX,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21),… Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour… Amerisource Health Services Terminated
Class II March 22, 2017 Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only,… CGMP Deviations Isomeric Pharmacy Solution, LLC Terminated
Class II March 22, 2017 HYDROQUINONE SOLUTION in all strengths including 4%, 28%, Rx only, Synergy RX, 4901… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLYCOLIC ACID… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only,… Failed Impurities/Degradation Specifications Teva Pharmaceuticals USA Terminated
Class II March 22, 2017 TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA 10%/LACTIC… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, Ascorbic… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hydrocortisone… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), Rx only, Synergy RX, 4901… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4%… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 4901 Morena… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ENHANCED RETIN ANTI-WRINKLE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in all strengths… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only, Synergy RX,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class III March 22, 2017 Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles… CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. G & W Laboratories, Inc. Terminated
Class II March 22, 2017 HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic acid 2%,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Rx… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydrocortisone… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX, 4901… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL,… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class II March 22, 2017 RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID… Lack of Assurance of Sterility: There are also CGMP Deviations. Synergy Rx Terminated
Class III March 22, 2017 Protonix PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per… Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. Pfizer Inc. Terminated
Class III March 22, 2017 PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE,… Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. Colgate Palmolive Co Terminated
Class III March 15, 2017 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC… Failed Dissolution Specifications: low out of specification dissolution results found during stability testing. Teva Pharmaceuticals USA Terminated
Class II March 15, 2017 calcipotriene Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube… Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and… LEO PHARMA INC Terminated
Class III March 15, 2017 Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only,… Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month… Actavis Inc Terminated
Class II March 15, 2017 Mirtazapine Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx… Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle Mylan Pharmaceuticals Inc. Terminated
Class II March 15, 2017 Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only,… Failed Dissolution Specifications Sandoz Inc Terminated
Class II March 15, 2017 Mirtazapine Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan… Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II March 15, 2017 Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets… Presence of Foreign Substance: foreign material found in the bulk inventory. Mckesson Packaging Services Completed
Class II March 15, 2017 Edex Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,… Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks Endo Pharmaceuticals, Inc. Terminated
Class II March 8, 2017 Cyclosporine CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed… Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total… Amerisource Health Services Terminated
Class II March 8, 2017 Alfuzosin Hydrochloride Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only,… Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken… Sun Pharmaceutical Industries, Inc. Terminated
Class III March 8, 2017 Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel… Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an… L. Perrigo Company Terminated
Class I March 8, 2017 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778… Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. United Exchange Corporation Terminated
Class II March 8, 2017 glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan… Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets Mylan Pharmaceuticals Inc. Terminated
Class II March 8, 2017 Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby… Lack of assurance of sterility United Exchange Corporation Terminated
Class I March 8, 2017 Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles,… Marketed without an approved NDA/ANDA for which safety and efficacy has not been established. Jeffreys Drug Store Terminated
Class II March 8, 2017 Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211… Lack of assurance of sterility United Exchange Corporation Terminated
Class III March 8, 2017 Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham,… Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an… L. Perrigo Company Terminated
Class I March 8, 2017 Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular… Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain… Pacific Medical Solutions Terminated
Class II March 8, 2017 Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30,… Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known… G & W Laboratories, Inc. Terminated
Class II March 8, 2017 HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged… cGMP deviations - presence of rubber particles found loose in the bulk product. Allegiant Health Terminated
Class III March 8, 2017 Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister… Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc. Terminated
Class II March 8, 2017 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778… Lack of assurance of sterility United Exchange Corporation Terminated
Class III March 8, 2017 ZENATANE Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister… Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc. Terminated
Class III March 8, 2017 ZENATANE Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister… Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc. Terminated
Class III March 8, 2017 ZENATANE Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister… Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc. Terminated
Class II March 8, 2017 Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette,… Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability… AbbVie Inc. Terminated
Class II March 1, 2017 MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1… CGMP Deviations Cherry Hill Sales Co. Terminated
Class II March 1, 2017 Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC… Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch"… Sandoz Inc Terminated
Class II March 1, 2017 METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container,… Lack of Sterility Assurance: customer report of leaking bag Hospira Inc., A Pfizer Company Terminated
Class II March 1, 2017 Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only,… Superpotent Drug and Subpotent Drug; potency failures obtained MOORE'S COMPOUNDING PHARMACY Terminated
Class II March 1, 2017 MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China,… CGMP Deviations Cherry Hill Sales Co. Terminated
Class II March 1, 2017 Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ… Failed Dissolution Specifications RemedyRepack Inc. Terminated
Class III March 1, 2017 Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer,… Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with… Sage Products Inc Terminated
Class II March 1, 2017 MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube,… CGMP Deviations Cherry Hill Sales Co. Terminated
Class II March 1, 2017 MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E,… CGMP Deviations Cherry Hill Sales Co. Terminated
Class II March 1, 2017 MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in… CGMP Deviations Cherry Hill Sales Co. Terminated
Class II March 1, 2017 Cyclosporine CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex,… Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total… Apotex Inc. Terminated
Class II February 22, 2017 Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare,… Failed tablet/capsule specification: missing break line on the 5mg tablet. Accord Healthcare, Inc. Terminated
Class II February 22, 2017 Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets… Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity. Teva Pharmaceuticals USA Terminated
Class II February 22, 2017 Venlafaxine Hydrochloride Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only,… Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. Aurobindo Pharma USA Inc Terminated
Class I February 22, 2017 SLIMFIT X capsules, packaged in a 60-cont bottle Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine. Jersey Shore Supplements, LLC Terminated
Class I February 22, 2017 MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20… Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical… MS Bionic Terminated
Class II February 22, 2017 Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By… Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing… Actavis Inc Terminated
Class III February 22, 2017 Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension,… Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert… LEO PHARMA INC Terminated
Class III February 15, 2017 Olanzapine Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr.… Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C… Dr. Reddy's Laboratories, Inc. Terminated
Class II February 15, 2017 Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose… Defective Container: Leakage of unit dose cups that may occur at the seal. VistaPharm, Inc. Terminated
Class III February 15, 2017 Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc.,… Superpotent Drug: Product may not meet specifications throughout shelf life. Apotex Inc. Terminated
Class III February 15, 2017 Pantoprazole Sodium Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in… Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. Aurobindo Pharma USA Inc Terminated
Class III February 8, 2017 Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in… Subpotent Drug Ecolab, Inc. Terminated
Class II February 8, 2017 Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class III February 8, 2017 Finasteride Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber… Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product. Hetero Drugs Ltd. - Unit 1 Terminated
Class II February 8, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a)… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Fluconazole Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's… Failed Dissolution Specifications; 18 month stability time point Dr. Reddy's Laboratories, Inc. Terminated
Class II February 8, 2017 Fluconazole Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC… Failed Dissolution Specifications; 18 month stability time point Dr. Reddy's Laboratories, Inc. Terminated
Class II February 8, 2017 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only,… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only,… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Methadone Hydrochloride Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case,… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Fluconazole Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC… Failed Dissolution Specifications; 18 month stability time point Dr. Reddy's Laboratories, Inc. Terminated
Class II February 8, 2017 Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Fluconazole Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC… Failed Dissolution Specifications; 18 month stability time point Dr. Reddy's Laboratories, Inc. Terminated
Class II February 8, 2017 Methadone Hydrochloride Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia… VistaPharm, Inc. Terminated
Class II February 8, 2017 Midazolam MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx… Failed Impurities/Degradation Specifications Fresenius Kabi USA, LLC Terminated
Class II February 8, 2017 Carbidopa and Levodopa Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC… Failed Dissolution Specifications Sun Pharmaceutical Industries, Inc. Terminated
Class II February 1, 2017 Furosemide Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc.,… Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. Roxane Laboratories, Inc. Terminated
Class II February 1, 2017 Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in… Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected… Cambrex Charles City Inc Terminated
Class II February 1, 2017 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b)… Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in… Mylan LLC. Terminated
Class II February 1, 2017 Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc.,… Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in… Mylan LLC. Terminated
Class III February 1, 2017 Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged… Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing… Roxane Laboratories, Inc. Terminated
Class II February 1, 2017 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx… Subpotency: due to a low, out of specification test result for assay during stability testing. Teva Pharmaceuticals USA Terminated
Class II February 1, 2017 Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b)… Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in… Mylan LLC. Terminated
Class III February 1, 2017 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx… Failed Dissolution Specifications; 18 month stability time point Sun Pharmaceutical Industries, Inc. Terminated
Class II February 1, 2017 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b)… Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in… Mylan LLC. Terminated
Class III February 1, 2017 DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST… Failed Impurities/ Degradation Specifications Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals Terminated
Class III February 1, 2017 Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only,… Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Actavis Inc Terminated
Class III February 1, 2017 bupropion hydrochloride buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC… Failed Dissolution Specifications; 18 month stability time point Sun Pharmaceutical Industries, Inc. Terminated
Class III January 25, 2017 Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC… Subpotent Drug: out of specification results for assay test. Sandoz Inc Terminated
Class III January 25, 2017 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC… Failed Dissolution Specifications Teva Pharmaceuticals USA Terminated
Class III January 25, 2017 Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count… Subpotent Drug: Out of specification result for pramoxine hydrochloride Novum Pharma, LLC Terminated
Class III January 25, 2017 HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town &… Subpotent Drug: due to failed potency results of 74% (spec. 80-125%). Town and Country Compounding and Consultation Services, LLC Terminated
Class III January 25, 2017 Pentasa Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only,… Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules Shire PLC Terminated
Class II January 25, 2017 Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only,… Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap L. Perrigo Company Terminated
Class III January 18, 2017 HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D… Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The… Pharm D Solutions, LLC Terminated
Class III January 18, 2017 Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM… Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed… Pharm D Solutions, LLC Terminated
Class II January 18, 2017 Daytrana Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3… Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the… Noven Pharmaceuticals, Inc. Terminated
Class II January 18, 2017 Daytrana Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2… Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the… Noven Pharmaceuticals, Inc. Terminated
Class II January 18, 2017 Daytrana Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours… Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the… Noven Pharmaceuticals, Inc. Terminated
Class III January 18, 2017 Cytotec Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For… Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and… Pfizer Inc. Terminated
Class II January 18, 2017 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter… Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of… Baxter Healthcare Corporation Terminated
Class II January 11, 2017 Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701… CGMP Deviations Gentell, Inc Terminated
Class II January 11, 2017 Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml +… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing