September 9, 2020DrugsFDA
SG24 LLC recalls Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
Hazard: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
September 9, 2020DrugsFDA
SG24 LLC recalls SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147
Hazard: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
September 9, 2020DrugsFDA
SG24 LLC recalls SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573
Hazard: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
September 9, 2020DrugsFDA
AAA Cosmetica, SA de CV recalls bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corpo
Hazard: Chemical Contamination: Product contains methanol.
September 9, 2020DrugsFDA
AAA Cosmetica, SA de CV recalls bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corpo
Hazard: CGMP Deviations
September 9, 2020DrugsFDA
Leiper's Fork Distillery recalls Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL,
Hazard: Labeling Not Elsewhere Classified: Product labeled to contain methanol.
September 9, 2020DrugsFDA
Soluciones Cosmeticas, SA de CV recalls Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New
Hazard: cGMP Deviations
September 9, 2020DrugsFDA
ROQUE PLAST, S.A. DE C.V. recalls Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Ado
Hazard: CGMP Deviation: Potential contamination with undeclared methanol.
September 9, 2020DrugsFDA
Grato Holdings, Inc. recalls HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy,
Hazard: Labeling: Error on Declared Strength
September 9, 2020DrugsFDA
Santa Cruz Biotechnology, Inc recalls UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured
Hazard: Subpotent drug
September 9, 2020DrugsFDA
Laboratorios Jaloma S.A. de C.V. recalls Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC
Hazard: cGMP deviations
September 2, 2020DrugsFDA
SCA Pharmaceuticals recalls Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Us
Hazard: 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.
September 2, 2020DrugsFDA
SCA Pharmaceuticals recalls Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use
Hazard: 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.
September 2, 2020DrugsFDA
SCA Pharmaceuticals recalls Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use
Hazard: 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.
September 2, 2020DrugsFDA
SCA Pharmaceuticals recalls Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use
Hazard: 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.
September 2, 2020DrugsFDA
RESOURCE RECOVERY & TRADING LLC recalls HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by:
Hazard: cGMP deviations
September 2, 2020DrugsFDA
RESOURCE RECOVERY & TRADING LLC recalls Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA,
Hazard: cGMP deviations
September 2, 2020DrugsFDA
Hetero Labs Limited (Unit V) recalls Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscat
Hazard: Failed Tablet/Capsule Specification; complaint of bulging tablet
September 2, 2020DrugsFDA
BAYSHORE PHARMACEUTICALS recalls Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceutical
Hazard: CGMP Deviations
September 2, 2020DrugsFDA
BAYSHORE PHARMACEUTICALS recalls Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceutica
Hazard: CGMP Deviations
September 2, 2020DrugsFDA
Par Pharmaceutical Inc. recalls BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Hazard: Failed Impurity /Degradation Specifications
September 2, 2020DrugsFDA
The Mentholatum Company recalls Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets
Hazard: 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.
September 2, 2020DrugsFDA
Yusef Manufacturing Laboratories, LLC recalls Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.1
Hazard: Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
September 2, 2020DrugsFDA
Ecolab Inc recalls Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, N
Hazard: Discoloration and Presence of Foreign Substance
September 2, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, prese
Hazard: Cross Contamination with other products: trace amounts of lidocaine
September 2, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distribu
Hazard: Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
September 2, 2020DrugsFDA
Medichem S.A. recalls Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Cel
Hazard: Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
September 2, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:
Hazard: Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
August 26, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distri
Hazard: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.