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 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0459-2016 | 10-19-2015 | Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 39 containers | Class II | Terminated |
| D-0480-2016 | 10-19-2015 | Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0408-2016 | 10-19-2015 | Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0416-2016 | 10-19-2015 | Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 conatiners | Class II | Terminated |
| D-0427-2016 | 10-19-2015 | Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0446-2016 | 10-19-2015 | Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0462-2016 | 10-19-2015 | Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0443-2016 | 10-19-2015 | Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0414-2016 | 10-19-2015 | Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 46 containers | Class II | Terminated |
| D-0438-2016 | 10-19-2015 | N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0426-2016 | 10-19-2015 | Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0435-2016 | 10-19-2015 | Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0395-2016 | 10-19-2015 | Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0465-2016 | 10-19-2015 | Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0445-2016 | 10-19-2015 | Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0397-2016 | 10-19-2015 | B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0431-2016 | 10-19-2015 | Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0398-2016 | 10-19-2015 | Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0448-2016 | 10-19-2015 | Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 15 containers | Class II | Terminated |
| D-0455-2016 | 10-19-2015 | T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0463-2016 | 10-19-2015 | Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 36 containers | Class II | Terminated |
| D-0338-2016 | 10-16-2015 | L-Tyrosine Injectable, 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 / 29 vials | Class II | Terminated |
| D-0366-2016 | 10-16-2015 | B12 Injection 12.5/12.5MG, 3mL, 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 / 98 vials | Class II | Terminated |
| D-0356-2016 | 10-16-2015 | Chromium 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 / 30 vials | Class II | Terminated |
| D-0363-2016 | 10-16-2015 | Calcium Gluconate (680mOsm/L) Injection 10%, 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 / 286 vials | Class II | Terminated |
| D-0384-2016 | 10-16-2015 | Methylcobalamin Injection Buffered 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 / 315 vials | Class II | Terminated |
| D-0378-2016 | 10-16-2015 | Thiamine HCl 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 / 72 vials | Class II | Terminated |
| D-0340-2016 | 10-16-2015 | EDTA Disodium Injectable, 150mg/mL, 100mL 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 / 2279 vials | Class II | Terminated |
| D-0359-2016 | 10-16-2015 | DMPS Injectable, 50mg/mL, 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 / 475 vials | Class II | Terminated |
| 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-0383-2016 | 10-16-2015 | MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/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 / 49 vials | Class II | Terminated |
| D-0379-2016 | 10-16-2015 | Testosterone Cypionate Injection (Sesame Oil), 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 / 34 vials | Class II | Terminated |
| D-0349-2016 | 10-16-2015 | Taurine Injectable, 50mg/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 / 123 vials | Class II | Terminated |
| D-0364-2016 | 10-16-2015 | Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 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 / 287 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-0375-2016 | 10-16-2015 | Dexpanthenol Injection, 250mg/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 / 235 vials | Class II | Terminated |
| D-0345-2016 | 10-16-2015 | Procaine Injectables 20mg/mL and 2%, 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 / 881 vials | Class II | Terminated |
| D-0339-2016 | 10-16-2015 | L-Tryptophan 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 / 16 vials | Class II | Terminated |
| D-0350-2016 | 10-16-2015 | Magnesium Sulfate 50% Injectable, 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 / 320 vials | Class II | Terminated |
| D-0367-2016 | 10-16-2015 | Magnesium Chloride Hexahydrate 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 / 289 vials | Class II | Terminated |
| D-0373-2016 | 10-16-2015 | Pyridoxine Injection, 100 mg/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 / 280 vials | Class II | Terminated |
| D-0365-2016 | 10-16-2015 | Hydroxocobalamin Injection (Buffered) 1mg/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 / 106 vials | Class II | Terminated |
| D-0347-2016 | 10-16-2015 | Vitamin D3 Injectable, 10,000 U/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 / 27 vials | Class II | Terminated |
| D-0351-2016 | 10-16-2015 | Cyanocobalamin Buffered Injectable 3mg/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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
