Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-03-22FDA-DrugSynergy RxClass IITRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 10%/ LACTIC ACID 12%, TRICHLOROCETIC ACID 6%/LACTIC ACID 12%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IISALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIRETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID SOLUTION LIQUID, 0.4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIRETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID 0.025%/CLINDAMYCIN 1.2% GEL, RETINOIC ACID 0.025%/ HYALURONIC ACID CREAM, RETINOIC ACID 0.05%/HYALURONIC ACID CREAM, RETINOIC ACID 0.1% IN CERAVE CREAM, RETINOIC ACID POWDER 1 GRAM, RETINOIC ACID/HYALURONIC ACID 0.1%/0.1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIGLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIGLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLYCOLIC ACID 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIFLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIFLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IICLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IICLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL CLINDAMYCIN 2.5%, BENZOYL PEROXIDE 5%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIBLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIBL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8% 6% CREAM, BLT 20%/ 8% /8% OINTMENT, BLT 20%/ 8% /8% CREAM, BLT 20%/ 7%/ 7% CREAM, BLT 20%/ 10%/ 4% CREAM, BLT 20%/ 10%/ 10% CREAM, BLT 20%/ 20%/ 10% OINTMENT,BLT 7%/ 10%/ 7% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIBENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN OI FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIBICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIMINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass II5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IITACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIKETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIHCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IICANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugSynergy RxClass IIHuman Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Lack of Assurance of Sterility: There are also CGMP Deviations.
- 2017-03-22FDA-DrugColgate Palmolive CoClass IIIPreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
- 2017-03-22FDA-DrugAmerisource Health ServicesClass IIGlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
- 2017-03-22FDA-DrugG & W Laboratories, Inc.Class IIIClindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
- 2017-03-22FDA-DrugIsomeric Pharmacy Solution, LLCClass IITriamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
CGMP Deviations
- 2017-03-22FDA-DrugTeva Pharmaceuticals USAClass IIBuprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
Failed Impurities/Degradation Specifications
- 2017-03-22FDA-DrugPfizer Inc.Class IIIPROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per ca
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
- 2017-03-15FDA-DrugSandoz IncClass IIPioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
Failed Dissolution Specifications
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