Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 10, 2025 and include a total of 17129 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0579-2017 | 02-10-2017 | TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, 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-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 |
| D-0552-2017 | 02-10-2017 | CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0490-2017 | 02-08-2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25 Package NDCs: 68084-879-95; 68084-879-25; 68084-921-95; 68084-921-25 | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities | Amerisource Health Services / 454 cartons | Class II | Terminated |
| D-0637-2017 | 02-08-2017 | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. Package NDCs: 39822-1030-1; 39822-1030-2 | Presence of Particulate Matter | X-Gen Pharmaceuticals Inc. / 2593 cartons | Class I | Terminated |
| D-0482-2017 | 02-07-2017 | Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02 | Failed Dissolution Specifications | RemedyRepack Inc. / 630 pills (21 bottles x 30 pills per HDPE bottle) | Class II | Terminated |
| D-0517-2017 | 02-07-2017 | Buprenorphine 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 | Teva Pharmaceuticals USA / 7,628 HDPE bottles (228,840 tablets) | Class II | Terminated |
| D-0501-2017 | 02-07-2017 | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43 | Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing. | G & W Laboratories, Inc. / 3456 boxes | Class II | Terminated |
| D-0514-2017 | 02-07-2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05 | Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point. | Actavis Inc / 14280 bottles | Class III | Terminated |
| D-0642-2017 | 02-03-2017 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 490 bags | Class I | Terminated |
| D-0644-2017 | 02-03-2017 | Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 30 bags | Class I | Terminated |
| D-0641-2017 | 02-03-2017 | Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 716 bags | Class I | Terminated |
| D-0475-2017 | 02-03-2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0 Package NDCs: 60505-0133-0; 60505-0133-2; 60505-0133-1; 60505-0134-0; 60505-0134-2; 60505-0134-1; 3605050134 | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities. | Apotex Inc. / 19,584 bottles | Class II | Terminated |
| D-0520-2017 | 02-03-2017 | GlipiZIDE 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. | Amerisource Health Services / 19,393 cartons (581,790 extended release tablets) | Class II | Terminated |
| D-0645-2017 | 02-03-2017 | Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 62 bags | Class I | Terminated |
| D-0639-2017 | 02-03-2017 | Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 50 bags | Class I | Terminated |
| D-0640-2017 | 02-03-2017 | Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 386 bags | Class I | Terminated |
| D-0643-2017 | 02-03-2017 | Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44 | Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. | SCA Pharmaceuticals / 50 bags | Class I | Terminated |
| D-0481-2017 | 02-02-2017 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540. | Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly. | Sandoz Inc / 157,922 cartons | Class II | Terminated |
| D-0479-2017 | 02-02-2017 | Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. | Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity. | Teva Pharmaceuticals USA / 17,473 cartons | Class II | Terminated |
| D-0489-2017 | 02-02-2017 | Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8. | Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package. | Sage Products Inc / 640 kits | Class III | Terminated |
| D-0860-2017 | 01-30-2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India. | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. | Mylan Pharmaceuticals Inc. / 43,848 cartons | Class III | Terminated |
| D-0476-2017 | 01-30-2017 | Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4 Package NDCs: 0591-0900-30; 0591-0844-01; 0591-0844-10; 0591-0845-01; 0591-0845-10; 0591090030 | Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point. | Actavis Inc / 499320 units | Class II | Terminated |
| D-0861-2017 | 01-30-2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India. Package NDCs: 0378-7280-85; 0378-7280-53 | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room. | Mylan Pharmaceuticals Inc. / 8,605 cartons | Class III | Terminated |
| D-0493-2017 | 01-27-2017 | Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20 Package NDCs: 51079-086-01; 51079-086-20; 51079-087-01; 51079-087-20; 51079-088-01; 51079-088-20 | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) | Class II | Terminated |
| D-0486-2017 | 01-27-2017 | MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28 | CGMP Deviations | Cherry Hill Sales Co. / 2,400 cartons | Class II | Terminated |
| D-0485-2017 | 01-27-2017 | MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28 | CGMP Deviations | Cherry Hill Sales Co. / 4,800 cartons | Class II | Terminated |
| D-0487-2017 | 01-27-2017 | MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35 | CGMP Deviations | Cherry Hill Sales Co. / 2,400 cartons | Class II | Terminated |
| D-0603-2017 | 01-27-2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466 | Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9% | Pharmedium Services, LLC / 3879 syringes | Class III | Terminated |
| D-0484-2017 | 01-27-2017 | MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28 | CGMP Deviations | Cherry Hill Sales Co. / 7,200 cartons | Class II | Terminated |
| D-0483-2017 | 01-27-2017 | MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28 | CGMP Deviations | Cherry Hill Sales Co. / 3,600 cartons | Class II | Terminated |
| D-0638-2017 | 01-24-2017 | Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01 | Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product. | Hospira Inc., A Pfizer Company / 30,880 vials | Class I | Terminated |
