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-1573-2020 | 08-14-2020 | Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 10,000 pens | Class I | Terminated |
| D-1571-2020 | 08-14-2020 | SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 9600 bottles | Class I | Terminated |
| D-1574-2020 | 08-14-2020 | Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 122,500 individual wipe packets | Class I | Terminated |
| D-1542-2020 | 08-10-2020 | BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 | Failed Impurity /Degradation Specifications | Par Pharmaceutical Inc. / 11,347 bottles | Class II | Terminated |
| D-1508-2020 | 08-10-2020 | Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37 | Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg | Lannett Company, Inc. / N/A | Class II | Terminated |
| D-1535-2020 | 08-10-2020 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05. Package NDCs: 65862-419-20; 65862-419-01; 65862-419-05; 65862-419-99; 65862-420-20; 65862-420-01; 65862-420-05; 65862-420-99 | Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). | Aurobindo Pharma USA Inc. / 5748 bottles | Class II | Terminated |
| D-1507-2020 | 08-10-2020 | Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75 Package NDCs: 0024-5150-10; 0024-5154-11; 0024-5152-11; 0024-5151-75; 0024-5155-74; 0024-5153-74 | Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing. | Sanofi-Aventis U.S. LLC / 7451 vials | Class II | Ongoing |
| D-1557-2020 | 08-07-2020 | UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220 | Subpotent drug | Santa Cruz Biotechnology, Inc / 14,238 bottles | Class II | Terminated |
| D-1564-2020 | 08-07-2020 | Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Open Book Extracts / 2880 boxes | Class II | Terminated |
| D-1563-2020 | 08-07-2020 | Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030) | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Open Book Extracts / 340,000 packs | Class II | Terminated |
| D-1545-2020 | 08-06-2020 | Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India | Failed Tablet/Capsule Specification; complaint of bulging tablet | Hetero Labs Limited (Unit V) / 43,512 bottles | Class II | Terminated |
| D-0659-2022 | 08-06-2020 | Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-0667-2022 | 08-06-2020 | Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-0662-2022 | 08-06-2020 | Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 3 bottles | Class II | Terminated |
| D-0661-2022 | 08-06-2020 | Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 5 vials | Class II | Terminated |
| D-0666-2022 | 08-06-2020 | Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 5 syringes | Class II | Terminated |
| D-0664-2022 | 08-06-2020 | Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 3 bags | Class II | Terminated |
| D-0660-2022 | 08-06-2020 | Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 2 vials | Class II | Terminated |
| D-0663-2022 | 08-06-2020 | Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 8 bags | Class II | Terminated |
| D-0657-2022 | 08-06-2020 | Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 4 bags | Class II | Terminated |
| D-0658-2022 | 08-06-2020 | Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-0656-2022 | 08-06-2020 | Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 2 bags | Class II | Terminated |
| D-0665-2022 | 08-06-2020 | Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Lack of Assurance of Sterility | Family Pharmacy of Statesville / 1 bag | Class II | Terminated |
| D-1587-2020 | 08-06-2020 | Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX. | Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol. | Incredible Products, SA de CV / N/A | Class I | Terminated |
| D-1559-2020 | 08-04-2020 | Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2 | CGMP Deviation: Potential contamination with undeclared methanol. | ROQUE PLAST, S.A. DE C.V. / 311,038 bottles | Class II | Terminated |
| D-1500-2020 | 08-04-2020 | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125 | cGMP Deviations. | Eosera, Inc. / 43,424 bottles | Class II | Terminated |
| D-1498-2020 | 08-04-2020 | Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8 | cGMP Deviations. | Eosera, Inc. / 45,673 bottles | Class II | Terminated |
| D-1499-2020 | 08-04-2020 | Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2 | cGMP Deviations. | Eosera, Inc. / 125,874 bottles | Class II | Terminated |
| D-1501-2020 | 08-04-2020 | Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5 | cGMP Deviations. | Eosera, Inc. / 15229 bottles | Class II | Terminated |
| D-1494-2020 | 08-04-2020 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16 Package NDCs: 0121-0810-02; 0121-0810-16; 0121-4810-05; 0121-4810-40; 0121-4810-00; 0121-4810-50 | Subpotent drug: Out of specification for assay at the 15-month test interval. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 7416 bottles | Class II | Terminated |
| D-1561-2020 | 08-03-2020 | Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery | Labeling Not Elsewhere Classified: Product labeled to contain methanol. | Leiper's Fork Distillery / 1996 gallons | Class II | Terminated |
| D-1513-2020 | 08-03-2020 | Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139, | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. | Ultra Seal Corporation / 701,735 packets | Class III | Terminated |
| D-1512-2020 | 08-03-2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007 | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. | Ultra Seal Corporation / 4,666,355 packets | Class III | Terminated |
| D-1555-2020 | 07-31-2020 | Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico. | cGMP deviations | Laboratorios Jaloma S.A. de C.V. / 211,875 bottles | Class II | Terminated |
| D-1541-2020 | 07-31-2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8 Package NDCs: 10742-8902-1 | Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not. | The Mentholatum Company / 31,732 Blister Packs | Class III | Terminated |
| D-0079-2021 | 07-30-2020 | Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz (237 mL) bottle, Distributed by: Midwood brands, LLC 10611 Monroe RD. Mathews, NC 28105 Made in Mexico UPC 3 2251 38042 6 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 2,760 bottles | Class II | Ongoing |
| D-1539-2020 | 07-30-2020 | Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21 | Discoloration and Presence of Foreign Substance | Ecolab Inc / 305 drums | Class II | Terminated |
| D-0081-2021 | 07-30-2020 | Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico, UPC 639277928597 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 19,992 bottles | Class II | Ongoing |
| D-0078-2021 | 07-30-2020 | NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 1,441,548 bottles | Class II | Ongoing |
| D-0080-2021 | 07-30-2020 | Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 27,000 bottles | Class II | Ongoing |
| D-0082-2021 | 07-30-2020 | NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ML) bottle, Made in Mexico, Distributed by: Genomma Lab USA Inc., Houston, TX 77027. UPC 6 50240 05357 3 | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Albek De Mexico S.A. De C.V. / 4,598,788 bottles | Class II | Ongoing |
| D-1552-2020 | 07-29-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 1,527 Containers | Class I | Terminated |
| D-1550-2020 | 07-29-2020 | Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 1,097 Containers | Class I | Terminated |
| D-1551-2020 | 07-29-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 366 Containers | Class I | Terminated |
| D-1495-2020 | 07-29-2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46 | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | SCA Pharmaceuticals / 3,932 bags | Class II | Terminated |
| D-1553-2020 | 07-29-2020 | Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246. | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens. | SCA Pharmaceuticals / 362 Containers | Class I | Terminated |
| D-1530-2020 | 07-27-2020 | Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1531-2020 | 07-27-2020 | Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1532-2020 | 07-27-2020 | Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940. | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1525-2020 | 07-27-2020 | Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1523-2020 | 07-27-2020 | Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1527-2020 | 07-27-2020 | Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1549-2020 | 07-27-2020 | HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013 | cGMP deviations | RESOURCE RECOVERY & TRADING LLC / 115 bottles | Class II | Completed |
| D-1516-2020 | 07-27-2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1521-2020 | 07-27-2020 | Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1520-2020 | 07-27-2020 | Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1522-2020 | 07-27-2020 | Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC. | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1518-2020 | 07-27-2020 | Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1514-2020 | 07-27-2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1515-2020 | 07-27-2020 | Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1526-2020 | 07-27-2020 | Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1524-2020 | 07-27-2020 | Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1519-2020 | 07-27-2020 | Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1517-2020 | 07-27-2020 | Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1528-2020 | 07-27-2020 | Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1548-2020 | 07-27-2020 | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020 | cGMP deviations | RESOURCE RECOVERY & TRADING LLC / 17,280 bottles | Class II | Completed |
| D-1529-2020 | 07-27-2020 | Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1578-2020 | 07-27-2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; , Made in Mexico by: Broncolin, S.A. de C.V. Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, C.P. 08500, Cuidad de Mexico, Mexico. Importer/Distributor: INBC TRADING LLC 4404 Merle Drive, Austin, TX 78745. | Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol. | Broncolin, S.A. de C.V. / 26,972 bottle | Class I | Terminated |
| D-1577-2020 | 07-27-2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 16.9 fl. oz. (500 ml) bottle, UPC 7 14706 91366 2; and d) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; Made in Mexico by: Broncolin, S.A. de C.V. Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, C.P. 08500, Cuidad de Mexico, Mexico. Importer/Distributor: INBC TRADING LLC 4404 Merle Drive, Austin, TX 78745 | CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Broncolin, S.A. de C.V. / 482,416 bottles | Class II | Terminated |
| D-1497-2020 | 07-24-2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Golden State Medical Supply Inc. / N/A | Class III | Terminated |
| D-1487-2020 | 07-24-2020 | VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35. | cGMP deviations | Vilvet Pharmaceuticals Inc. / 11,640 bottles | Class II | Terminated |
| D-1488-2020 | 07-24-2020 | VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24. | cGMP deviations | Vilvet Pharmaceuticals Inc. / 1,716 bottles | Class II | Terminated |
| D-1579-2020 | 07-23-2020 | scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1 | CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 504,000 pieces | Class II | Terminated |
| D-1583-2020 | 07-23-2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018. | Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / N/A | Class I | Terminated |
| D-1582-2020 | 07-23-2020 | LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02 | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 90,288 bottles | Class II | Terminated |
| D-1581-2020 | 07-23-2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018. | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 975,720 bottles | Class II | Terminated |
| D-1580-2020 | 07-23-2020 | scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1 | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 917,280 bottles | Class II | Terminated |
| D-1537-2020 | 07-22-2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05 | Cross Contamination with other products: trace amounts of lidocaine | Fresenius Kabi USA, LLC / 25,100 bottles | Class I | Terminated |
| D-1490-2020 | 07-22-2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10 Package NDCs: 0054-4496-25; 0054-4496-13; 0054-4497-10; 0054-4497-05; 0054-4498-10; 0054-4499-11; 0054-8496-19 | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | West-Ward Columbus Inc / 2300 bottles | Class III | Terminated |
| D-1504-2020 | 07-21-2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0 | Superpotent Drug | Ferring Pharmaceuticals Inc / 15,175 nasal sprays | Class I | Terminated |
| D-1505-2020 | 07-21-2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05 | Superpotent Drug | Ferring Pharmaceuticals Inc / 184,325 nasal sprays | Class I | Terminated |
| D-1506-2020 | 07-21-2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00 | Superpotent Drug | Ferring Pharmaceuticals Inc / 29,371 nasal sprays | Class I | Terminated |
| D-1502-2020 | 07-21-2020 | Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India. | Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. | Lupin Pharmaceuticals Inc. / 560,922 Pouches | Class II | Terminated |
| D-0254-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.UPC # 7 501799 118998 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 575 drums | Class I | Terminated |
| D-1496-2020 | 07-20-2020 | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Taro Pharmaceuticals U.S.A., Inc. / 7632 tubes | Class III | Terminated |
| D-0256-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.; UPC # 7 501799 118981 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 1 tank | Class I | Terminated |
| D-0253-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 12,201 bottles | Class I | Terminated |
| D-0255-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477; NDC: XXXXX-378-04, UPC # 7 501799 118837 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 6,597 gallons | Class I | Terminated |
| D-1446-2020 | 07-20-2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12 Package NDCs: 0409-9093-41; 0409-9093-36; 0409-9093-31; 0409-9093-38; 0409-9094-12; 0409-9094-22; 0409-9094-18; 0409-9094-25; 0409-9094-17; 0409-9094-28; 0409-9094-16; 0409-9094-31; 0409-9094-41; 0409-9094-61 | Lack of Assurance of Sterility; potential loose metal overseal crimp defects. | Pfizer Inc. / 19,144 vials | Class II | Terminated |
| D-1413-2020 | 07-17-2020 | Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08 Package NDCs: 68001-337-00; 68001-337-08; 68001-332-00; 68001-332-03; 68001-333-00; 68001-333-08; 68001-486-00; 68001-486-08; 68001-334-00; 68001-334-08; 68001-335-00; 68001-335-08; 68001-336-00 | Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg | Lupin Pharmaceuticals Inc. / 11,688 bottles | Class II | Terminated |
| D-1558-2020 | 07-16-2020 | HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1 | Labeling: Error on Declared Strength | Grato Holdings, Inc. / 850 bottles | Class II | Terminated |
| D-1560-2020 | 07-14-2020 | Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7 | cGMP Deviations | Soluciones Cosmeticas, SA de CV / 2,486,400 bottles | Class II | Terminated |
| D-1492-2020 | 07-14-2020 | Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30 Package NDCs: 0591-3525-11; 0591-3525-30 | Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton. | Teva Pharmaceuticals USA / 28,596 cartons | Class II | Terminated |
| D-1391-2020 | 07-13-2020 | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 Package NDCs: 63323-972-10 | Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial. | Fresenius Kabi USA, LLC / 63,067 vials | Class III | Terminated |
| D-0054-2021 | 07-13-2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15 | SUBPOTENT DRUG | Bausch Health Companies, Inc. / 35424 units | Class II | Terminated |
| D-0022-2021 | 07-11-2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0031-2021 | 07-11-2020 | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class I | Terminated |
| D-0026-2021 | 07-11-2020 | ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0029-2021 | 07-11-2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class I | Terminated |
| D-0025-2021 | 07-11-2020 | blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7 | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
