Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0646-2017 | 02-16-2017 | XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768 | Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED). | Organic Herbal Supply / 100,000 to 150,000 capsules | Class I | Terminated |
| D-0854-2017 | 02-16-2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01. | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. | Sato Pharmaceutical Inc. / 10,130 bottles | Class II | Terminated |
| D-0856-2017 | 02-16-2017 | DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01 | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. | Sato Pharmaceutical Inc. / 14,325 bottles | Class II | Terminated |
| D-0855-2017 | 02-16-2017 | SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01 | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. | Sato Pharmaceutical Inc. / 4,790 bottles | Class II | Terminated |
| D-0506-2017 | 02-15-2017 | Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed dissolution specifications - low dissolution results at S3 stage. | Dr. Reddy's Laboratories, Inc. / 4032 cartons | Class III | Terminated |
| D-0509-2017 | 02-15-2017 | Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed dissolution specifications - low dissolution results at S3 stage. | Dr. Reddy's Laboratories, Inc. / 4404 cartons | Class III | Terminated |
| D-0507-2017 | 02-15-2017 | Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81 Package NDCs: 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78 | Failed dissolution specifications - low dissolution results at S3 stage. | Dr. Reddy's Laboratories, Inc. / 12132 cartons | Class III | Terminated |
| D-0934-2017 | 02-15-2017 | Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 21 I.V. pumps | Class III | Terminated |
| D-0508-2017 | 02-15-2017 | Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81 | Failed dissolution specifications - low dissolution results at S3 stage. | Dr. Reddy's Laboratories, Inc. / 4014 cartons | Class III | Terminated |
| D-0932-2017 | 02-15-2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 147 I.V. pumps | Class III | Terminated |
| D-0933-2017 | 02-15-2017 | Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 10 I.V. pumps | Class III | Terminated |
| D-0930-2017 | 02-15-2017 | Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 79 I.V. pumps | Class III | Terminated |
| D-0931-2017 | 02-15-2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 22 I.V. pumps | Class III | Terminated |
| D-0936-2017 | 02-15-2017 | Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 7 I.V. pumps | Class III | Terminated |
| D-0610-2017 | 02-15-2017 | Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13 | Failed impurities/ degradation specifications: Product was above specification for unknown impurities. | AVKARE Inc. / 116 cartons | Class II | Terminated |
| D-0935-2017 | 02-15-2017 | Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57 | Labeling: Incorrect or Missing Lot and/or Exp Date | Pharmedium Services Llc / 2 I.V. pumps | Class III | Terminated |
| D-0504-2017 | 02-13-2017 | Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7. | Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity. | L. Perrigo Company / 10,656 units total for both products | Class III | Terminated |
| D-0503-2017 | 02-13-2017 | Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9. | Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity. | L. Perrigo Company / 10,656 units total for both products | Class III | Terminated |
| D-0521-2017 | 02-13-2017 | PreviDent 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 Package NDCs: 0126-0016-61; 3834110622 | Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. | Colgate Palmolive Co / 14,656 bottles | Class III | Terminated |
| D-0515-2017 | 02-10-2017 | Pioglitazone 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 | Sandoz Inc / N/A | Class II | Terminated |
| D-0542-2017 | 02-10-2017 | RETINOIC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0564-2017 | 02-10-2017 | MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0531-2017 | 02-10-2017 | BENZOYL 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0585-2017 | 02-10-2017 | HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0572-2017 | 02-10-2017 | SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0530-2017 | 02-10-2017 | ADAPALENE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0550-2017 | 02-10-2017 | ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic acid 2%, Clindamycin 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0537-2017 | 02-10-2017 | FLUORORACIL 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0571-2017 | 02-10-2017 | SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin OTC 2%, Azeliac acid OTC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0524-2017 | 02-10-2017 | HCG 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0588-2017 | 02-10-2017 | TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in all strengths including 0.1% and 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0522-2017 | 02-10-2017 | Human 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. | Synergy Rx / 1809 vials | Class II | Terminated |
| D-0525-2017 | 02-10-2017 | KETOCONAZOLE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0526-2017 | 02-10-2017 | TACROLIMUS 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0582-2017 | 02-10-2017 | ENHANCED RETIN ANTI-WRINKLE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0566-2017 | 02-10-2017 | MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0541-2017 | 02-10-2017 | RETINOIC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0527-2017 | 02-10-2017 | 5-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. | Synergy Rx / N/A | Class II | Terminated |
| D-0532-2017 | 02-10-2017 | BL 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0554-2017 | 02-10-2017 | CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0574-2017 | 02-10-2017 | TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0539-2017 | 02-10-2017 | GLYCOLIC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0543-2017 | 02-10-2017 | SALICYLIC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0601-2017 | 02-10-2017 | INTIMATE BLEACHING 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0533-2017 | 02-10-2017 | BLEACHING 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0548-2017 | 02-10-2017 | HYDROQUINONE SOLUTION in all strengths including 4%, 28%, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0581-2017 | 02-10-2017 | BETAMETHASONE 0.25%, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0553-2017 | 02-10-2017 | CLARIFYING CREAM (Retinoic acid 0.025%, Salicylic Acid 1%, Green tea powder, Ascorbic acid 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0573-2017 | 02-10-2017 | TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA 10%/LACTIC ACID 12%, TCA 6%/ LACTIC ACID12%, TCA 7%/SALICYLIC ACID 2% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0599-2017 | 02-10-2017 | CUSTOM LIGHTENING/BRIGHTENING 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0567-2017 | 02-10-2017 | QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hydrocortisone 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0568-2017 | 02-10-2017 | QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0578-2017 | 02-10-2017 | VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0549-2017 | 02-10-2017 | LACTIC ACID SOLUTION in all strengths including 20%, 30%, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0561-2017 | 02-10-2017 | JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0584-2017 | 02-10-2017 | HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0583-2017 | 02-10-2017 | ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN 0.025% and 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0555-2017 | 02-10-2017 | CLEAR 2 (Benzoyl Peroxide 2.5%, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0602-2017 | 02-10-2017 | KOJIC ACID 8%/AZELAIC ACID 15% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0600-2017 | 02-10-2017 | GENTLE SUPREME BLEACHING 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0595-2017 | 02-10-2017 | METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0558-2017 | 02-10-2017 | GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0580-2017 | 02-10-2017 | DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0536-2017 | 02-10-2017 | ERYTHROMYCIN 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0593-2017 | 02-10-2017 | LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE 23%/TETRACAINE 7%/PRILOCAONE 2.5%, LIDOCAINE 24%/PRILOCAINE 26% OINTMENT, LIDOCAINE 30%/TETRACAINE 4% /PRILOCAINE 2%, LIDOCAINE 30%/PHENYLEPHRINE 0.25%, LIDOCAINE 30%/ TETRACAINE 10%, MELYLEPHRINE 4%, LIDOCAINE 30%/TETRACAINE 4%/PRILOCAINE, LIDOCAINE 7%/TETRACAINE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0562-2017 | 02-10-2017 | LP CREAM (Lidocaine 15%/Prilocaine 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0577-2017 | 02-10-2017 | ULTRA LITE CREAM (Hydroquinone 8%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0545-2017 | 02-10-2017 | UREA 40% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0594-2017 | 02-10-2017 | AZELAIC ACID 15% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0556-2017 | 02-10-2017 | DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 0.1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0563-2017 | 02-10-2017 | MALEK'S MAGIC (retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0592-2017 | 02-10-2017 | RETIN-A 0.05% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0586-2017 | 02-10-2017 | HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,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. | Synergy Rx / N/A | Class II | Terminated |
| D-0576-2017 | 02-10-2017 | TRI-BLEACHING CREAM HQ (retinoic Acid 0.05%, Hydroquinone 6%, Fluocinolone 0.01%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0480-2017 | 02-10-2017 | METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24 | Lack of Sterility Assurance: customer report of leaking bag | Hospira Inc., A Pfizer Company / 578,784 bags | Class II | Terminated |
| D-0575-2017 | 02-10-2017 | TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0587-2017 | 02-10-2017 | HYDROQUINONE 28% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0547-2017 | 02-10-2017 | HYDROQUINONE CREAM in all strengths including 4%, 5%,6%, 7%, 8%, HYDROQUINONE 5%/KOJIC ACID 3% 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0535-2017 | 02-10-2017 | CLOBETASOL 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0570-2017 | 02-10-2017 | REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0538-2017 | 02-10-2017 | FLUOCINONIDE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0528-2017 | 02-10-2017 | MINOXADIL 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0551-2017 | 02-10-2017 | BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, kojic acid 3%, hydrocortisone 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0569-2017 | 02-10-2017 | ROSACEA CREAM ( Metronidazole 1%, Niacinamide 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0544-2017 | 02-10-2017 | TRICHLOROACETIC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0598-2017 | 02-10-2017 | SULFUR 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0523-2017 | 02-10-2017 | CANTHARADIN 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0591-2017 | 02-10-2017 | PURIFIED WATER, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0540-2017 | 02-10-2017 | GLYCOLIC 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0560-2017 | 02-10-2017 | HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0529-2017 | 02-10-2017 | BICARBONATE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0597-2017 | 02-10-2017 | SULFACETAMIDE 10%/HYDROCORTISONE 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0596-2017 | 02-10-2017 | HYDROCORTISONE 2.5% WITH ALOE VERA 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0546-2017 | 02-10-2017 | VITAMIN K OXIDE 5%, HQ 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0565-2017 | 02-10-2017 | LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0557-2017 | 02-10-2017 | FIRM AND FADE (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0590-2017 | 02-10-2017 | MELATONIN 1.5MG SPRAY, 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0589-2017 | 02-10-2017 | TRETINOIN 0.02% IN OIL 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0559-2017 | 02-10-2017 | GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%), 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. | Synergy Rx / N/A | Class II | Terminated |
| D-0534-2017 | 02-10-2017 | CLINDAMYCIN 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. | Synergy Rx / N/A | Class II | Terminated |
