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 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0806-2017 | 02-22-2017 | Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0824-2017 | 02-22-2017 | Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0827-2017 | 02-22-2017 | Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0799-2017 | 02-22-2017 | NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0840-2017 | 02-22-2017 | Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0801-2017 | 02-22-2017 | Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0841-2017 | 02-22-2017 | Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0839-2017 | 02-22-2017 | Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0798-2017 | 02-22-2017 | RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0815-2017 | 02-22-2017 | Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0844-2017 | 02-22-2017 | Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0805-2017 | 02-22-2017 | Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0850-2017 | 02-22-2017 | Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0808-2017 | 02-22-2017 | Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0822-2017 | 02-22-2017 | Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0842-2017 | 02-22-2017 | Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0812-2017 | 02-22-2017 | Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0828-2017 | 02-22-2017 | Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0821-2017 | 02-22-2017 | Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0817-2017 | 02-22-2017 | Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0810-2017 | 02-22-2017 | Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0837-2017 | 02-22-2017 | Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0832-2017 | 02-22-2017 | Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0807-2017 | 02-22-2017 | ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0811-2017 | 02-22-2017 | Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054 | Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. | Advanced Pharma Inc. / | Class II | Terminated |
| D-0604-2017 | 02-21-2017 | A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981 | Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue. | Bayer HealthCare Pharmaceuticals, Inc. / a) 468,576 (1.5g); b) 203868 (3 oz) and c) 802,620 (4 oz) | Class III | Terminated |
| D-0906-2017 | 02-17-2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 216 bags | Class III | Terminated |
| D-0915-2017 | 02-17-2017 | VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 60 bags | Class II | Terminated |
| D-0914-2017 | 02-17-2017 | VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 816 bags | Class II | Terminated |
| D-0909-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 192 bags | Class III | Terminated |
| D-0911-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 672 bags | Class III | Terminated |
| D-0907-2017 | 02-17-2017 | Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 143 bags | Class III | Terminated |
| D-0910-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 912 bags | Class III | Terminated |
| D-0913-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 216 bags | Class III | Terminated |
| D-0511-2017 | 02-17-2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Failed Dissolution Specifications: low out of specification dissolution results found during stability testing. | Teva Pharmaceuticals USA / 25,916 cartons | Class III | Terminated |
| D-0912-2017 | 02-17-2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 48 bags | Class III | Terminated |
| D-0908-2017 | 02-17-2017 | Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 144 bags | Class II | Terminated |
| D-0916-2017 | 02-17-2017 | VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478 | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Pharmedium Services, LLC / 108 bags | Class II | Terminated |
| D-0500-2017 | 02-16-2017 | HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729 | cGMP deviations - presence of rubber particles found loose in the bulk product. | Allegiant Health / 70,176 bottles; 9,000,000 tablets (bulk) | Class II | Terminated |
| 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. Package NDCs: 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 Package NDCs: 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 Package NDCs: 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
