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-0370-2016 | 10-16-2015 | L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 467 vials | Class II | Terminated |
| D-0352-2016 | 10-16-2015 | Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 20 vials | Class II | Terminated |
| D-0342-2016 | 10-16-2015 | Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 4857 vials | Class II | Terminated |
| D-0341-2016 | 10-16-2015 | Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 108 vials | Class II | Terminated |
| D-0371-2016 | 10-16-2015 | Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 178 vials | Class II | Terminated |
| D-0355-2016 | 10-16-2015 | HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 1062 vials | Class II | Terminated |
| D-0377-2016 | 10-16-2015 | Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 74 vials | Class II | Terminated |
| D-0357-2016 | 10-16-2015 | EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 104 vials | Class II | Terminated |
| D-0344-2016 | 10-16-2015 | Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 25 vials | Class II | Terminated |
| D-0346-2016 | 10-16-2015 | Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 12 vials | Class II | Terminated |
| D-0362-2016 | 10-16-2015 | TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 481 vials | Class II | Terminated |
| D-0354-2016 | 10-16-2015 | Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 186 vials | Class II | Terminated |
| D-0360-2016 | 10-16-2015 | Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 160 vials | Class II | Terminated |
| D-0381-2016 | 10-16-2015 | Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 304 vials | Class II | Terminated |
| D-0372-2016 | 10-16-2015 | Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 28 vials | Class II | Terminated |
| D-0380-2016 | 10-16-2015 | Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 225 vials | Class II | Terminated |
| D-0343-2016 | 10-16-2015 | MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 502 vials | Class II | Terminated |
| D-0374-2016 | 10-16-2015 | DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 16 vials | Class II | Terminated |
| D-0353-2016 | 10-16-2015 | Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 2189 vials | Class II | Terminated |
| D-0358-2016 | 10-16-2015 | TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 171 vials | Class II | Terminated |
| D-0368-2016 | 10-16-2015 | L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 32 vials | Class II | Terminated |
| D-0369-2016 | 10-16-2015 | DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 187 vials | Class II | Terminated |
| D-0382-2016 | 10-16-2015 | Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 7 vials | Class II | Terminated |
| D-0361-2016 | 10-16-2015 | Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 23 vials | Class II | Terminated |
| D-0348-2016 | 10-16-2015 | Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 363 vials | Class II | Terminated |
| D-0337-2016 | 10-16-2015 | L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 14 vials | Class II | Terminated |
| D-0376-2016 | 10-16-2015 | M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 172 vials | Class II | Terminated |
| D-0848-2016 | 10-15-2015 | Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 66 bottles | Class II | Ongoing |
| D-0851-2016 | 10-15-2015 | Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 44 compacts | Class II | Ongoing |
| D-0850-2016 | 10-15-2015 | Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 45 compacts | Class II | Ongoing |
| D-0847-2016 | 10-15-2015 | Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 195 bottles | Class II | Ongoing |
| D-0846-2016 | 10-15-2015 | Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 354 bottles | Class II | Ongoing |
| D-0849-2016 | 10-15-2015 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 27 bottles | Class II | Ongoing |
| D-0842-2016 | 10-15-2015 | Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 542 bottles | Class II | Ongoing |
| D-0845-2016 | 10-15-2015 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 20 bottles | Class II | Ongoing |
| D-0844-2016 | 10-15-2015 | Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 15 bottles | Class II | Ongoing |
| D-0843-2016 | 10-15-2015 | Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016 | cGMP Deviations; product does not comply with cGMP requirements | Sesderma, SL / 459 bottles | Class II | Ongoing |
| D-0053-2016 | 10-13-2015 | Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10 Package NDCs: 59212-425-10; 59212-425-11; 59212-425-04 | Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide. | Rx PAK / 2530 bottles | Class III | Terminated |
| D-0572-2016 | 10-09-2015 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01 | Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product. | Mutual Pharmaceutical Company, Inc. / 9526 | Class II | Terminated |
| D-0387-2016 | 10-09-2015 | Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013 | Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance. | Qualgen / 10,885 vials | Class II | Terminated |
| D-0386-2016 | 10-09-2015 | Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013 | Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance. | Qualgen / 4,221 vials | Class II | Terminated |
| D-0175-2016 | 10-07-2015 | PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1 vial | Class II | Terminated |
| D-0174-2016 | 10-07-2015 | PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1-5 ml vial; 3-10 ml vials | Class II | Terminated |
| D-0165-2016 | 10-07-2015 | Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 2 vials | Class II | Terminated |
| D-0177-2016 | 10-07-2015 | PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 4 vials | Class II | Terminated |
| D-0172-2016 | 10-07-2015 | PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1 vial | Class II | Terminated |
| D-0166-2016 | 10-07-2015 | Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 2-10ml vials, 1-20ml vial | Class II | Terminated |
| D-0170-2016 | 10-07-2015 | PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1-5 ml vial, 3-10 ml vial | Class II | Terminated |
| D-0168-2016 | 10-07-2015 | Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 2 vials | Class II | Terminated |
| D-0167-2016 | 10-07-2015 | Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 3 vials | Class II | Terminated |
| D-0179-2016 | 10-07-2015 | PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1 vial | Class II | Terminated |
| D-0171-2016 | 10-07-2015 | PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 3 vials | Class II | Terminated |
| D-0173-2016 | 10-07-2015 | PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1 vial | Class II | Terminated |
| D-0232-2016 | 10-07-2015 | HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93. | Presence of Particulate Matter. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 912 HDPE bottles | Class II | Terminated |
| D-0176-2016 | 10-07-2015 | PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1- 5ml vial, 1- 10 ml vial | Class II | Terminated |
| D-0180-2016 | 10-07-2015 | PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1 vial | Class II | Terminated |
| D-0178-2016 | 10-07-2015 | PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 1 vial | Class II | Terminated |
| D-0169-2016 | 10-07-2015 | PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Pacific Healthcare, Inc dba B&B Pharmacy / 31 -10 ml vials; 16- 5 ml vials | Class II | Terminated |
| D-0157-2016 | 10-06-2015 | METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0158-2016 | 10-06-2015 | TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0160-2016 | 10-06-2015 | TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0156-2016 | 10-06-2015 | PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0159-2016 | 10-06-2015 | CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258 | Lack of Assurance of Sterility: all sterile compounded products within expiry | Chen Shwezin, Inc. dba Park Compounding Pharmacy / 2 vials | Class II | Terminated |
| D-0675-2016 | 10-05-2015 | NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827. | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. | Inaffit, LLC / 6000 Bottles | Class I | Terminated |
| D-0670-2016 | 10-01-2015 | Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | MSNV, Inc dba National Video Supply / 868 Bottles | Class I | Terminated |
| D-0671-2016 | 10-01-2015 | Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | MSNV, Inc dba National Video Supply / 460 Blister Packs | Class I | Terminated |
| D-0017-2016 | 10-01-2015 | Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; and c) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 49708-102-07, UPC 3 49708 10207 5; d) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 49708-102-90, UPC 3 49708 10290 7; e) Fenofibric Acid Tablets, 30-count bottles, NDC 53489-678-07, UPC 3 53489 67807 0; f) Fenofibric Acid Tablets, 90-count bottles, NDC 53489-678-90, UPC 3 53489 67890 2; Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Distributed by: Sun Pharmaceutical Industries, Inc, Cranbury, NJ 08512; g) Fenofibric Acid Tablets, 30-count bottles, Professional Sample, NDC 53489-678-87, UPC 3 53489-678-87 2; Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA. | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. | Tribute Pharmaceuticals US Inc. / 140,607 bottles | Class III | Terminated |
| D-0016-2016 | 10-01-2015 | Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product. | Tribute Pharmaceuticals US Inc. / 39,650 bottles | Class III | Terminated |
| D-0672-2016 | 09-30-2015 | Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | Premiere Sales Group / 337 bottles | Class I | Terminated |
| D-0673-2016 | 09-30-2015 | Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine. | Premiere Sales Group / | Class I | Terminated |
| D-0722-2016 | 09-29-2015 | Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1. | Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug. | Fit Firm and Fabulous / 3000 bottles | Class I | Terminated |
| D-0054-2016 | 09-29-2015 | Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29 | Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing. | Hospira Inc. / 24,100 Syringes | Class III | Ongoing |
| D-0525-2016 | 09-28-2015 | Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co, Deerfield, IL (NDC 0363-0495-66); Being Well brand distributed by Save-A-Lot Food Stores, Ltd, Earth City, MO (NDC 46994-458-66); CareOne brand distributed by FoodHold, USA LLC, Landover, MD (NDC 41520-458-66); Shoprite brand distributed by Wakefern Food, Corp, Keasbey, NJ (NDC 41190-458-66 UPC: 041190223343); Shopko brand distributed by Shopko Stores Operating Co., LLC, Green Bay, WI (NDC 37012-458-66 UPC: 370030677689); Western Family brand distributed by Western Family Foods, Inc., Portland, OR (NDC 55312-458-66 UPC: 015400121026) Package NDCs: 41163-458-39; 41163-458-66; 41163-458-72; 41163-458-76; 41163-458-95; 41163-458-58; 24385-998-74; 24385-998-65; 24385-998-75; 24385-998-58; 55910-699-66; 42507-458-30; 42507-458-39; 42507-458-66; 42507-458-60; 42507-458-72; 42507-458-45; 42507-458-95; 42507-458-90; 42507-458-75; 42507-458-06; 42507-458-00; 42507-458-87; 59779-458-13; 59779-458-39; 59779-458-95; 59779-458-75; 59779-458-76; 59779-458-88; 59779-458-66; 59779-458-72; 59779-458-70; 59779-458-58; 59779-458-06; 59779-458-00; 59779-458-05; 59779-458-01; 36800-458-13; 36800-458-66; 36800-458-39; 36800-458-95; 36800-458-72; 36800-458-75; 36800-458-47; 36800-458-87; 36800-458-06; 36800-458-58; 37808-458-66; 3700306594; 49738-458-66; 30142-458-66; 49781-106-14; 55316-458-66; 21130-458-66; 0363-0495-66; 46994-458-66; 41520-458-66; 41190-458-66; 0411902233; 37012-458-66; 3700306776; 55312-458-66; 0154001210 | Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester | Perrigo Company PLC / 209,256 cartons | Class III | Terminated |
| D-0012-2016 | 09-25-2015 | FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2. Package NDCs: 0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46 | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. | Boehringer Ingelheim Roxane Inc / 5,160 bottles | Class III | Terminated |
| D-0011-2016 | 09-25-2015 | FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8. Package NDCs: 0054-4297-31; 0054-4297-25; 0054-8297-25; 0054-4299-31; 0054-4299-25; 0054-8299-25; 0054-4301-29; 0054-4301-25; 0054-8301-25; 0054-3298-63; 0054-3294-50; 0054-3294-46 | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. | Boehringer Ingelheim Roxane Inc / 11,110 bottles | Class III | Terminated |
| D-0014-2016 | 09-25-2015 | Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3. | Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. | Actavis Laboratories, FL, Inc. / 13,284 bottles | Class II | Terminated |
| D-0771-2016 | 09-25-2015 | RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. | Tf Supplements / 350 Bottles | Class I | Terminated |
| D-0772-2016 | 09-25-2015 | Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748 | Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine. | Tf Supplements / 128 Blister Packs | Class I | Terminated |
| D-0663-2016 | 09-25-2015 | ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30. | Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. | Medline Industries Inc / | Class I | Terminated |
| D-0662-2016 | 09-25-2015 | ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30. | Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets. | Medline Industries Inc / 7,372 HDPE Bottles | Class I | Terminated |
| D-0161-2016 | 09-24-2015 | Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01 Package NDCs: 0009-0029-01; 0009-0029-46; 0009-0029-02; 0009-0029-14; 0009-0055-01; 0009-0055-46; 0009-0055-03; 0009-0055-15; 0009-0090-01; 0009-0090-04; 0009-0090-13; 0009-0094-01; 0009-0094-03 | Subpotent Drug | Pfizer Inc. / 21,120 HDPE bottles | Class II | Terminated |
| D-0006-2016 | 09-23-2015 | Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527 | Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance. | Diabetes Corporation of America dba DCA Pharmacy / 129 vials | Class II | Terminated |
| D-0879-2016 | 09-23-2015 | Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown | Class I | Terminated |
| D-0880-2016 | 09-23-2015 | Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown | Class I | Terminated |
| D-0881-2016 | 09-23-2015 | Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. | Lucy's Weight Loss (dba. Waisted With Lucy) / N/A | Class I | Terminated |
| D-0041-2016 | 09-22-2015 | P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 4 vials | Class II | Terminated |
| D-0052-2016 | 09-22-2015 | P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0044-2016 | 09-22-2015 | Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0045-2016 | 09-22-2015 | Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 2 bottles | Class II | Terminated |
| D-0040-2016 | 09-22-2015 | Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0013-2016 | 09-22-2015 | Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX 77043, UPC: 1 88436 00017 4. | Cross Contamination With Other Products: Potential cross-contamination of cephalosporin. | Midway Importing, Inc / 164,332 boxes | Class II | Terminated |
| D-0046-2016 | 09-22-2015 | Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 3 vials | Class II | Terminated |
| D-0051-2016 | 09-22-2015 | P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0042-2016 | 09-22-2015 | P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 4 vials | Class II | Terminated |
| D-0048-2016 | 09-22-2015 | P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0049-2016 | 09-22-2015 | P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0043-2016 | 09-22-2015 | Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0050-2016 | 09-22-2015 | P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 1 vial | Class II | Terminated |
| D-0047-2016 | 09-22-2015 | Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919 | Lack of assurance of sterility | Bedford Pharmacy / 2 vial | Class II | Terminated |
| D-0640-2016 | 09-18-2015 | Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Sentara Enterprises / 9 Bags | Class II | Terminated |
