March 2, 2022DrugsFDA
RISING PHARMACEUTICALS recalls Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceutic
Hazard: Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
March 2, 2022DrugsFDA
Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstic
Hazard: cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
March 2, 2022DrugsFDA
Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 f
Hazard: cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
March 2, 2022DrugsFDA
Professional Disposables International, Inc. recalls Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Max
Hazard: cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
March 2, 2022DrugsFDA
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy recalls Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Tele
Hazard: Subpotent drug
February 23, 2022DrugsFDA
Teligent Pharma, Inc. recalls Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Di
Hazard: Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
February 23, 2022DrugsFDA
Revive Rx LLC dba Revive Rx Pharmacy recalls HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded
Hazard: Non-sterility; bacterial contamination identified as Paenibacillus lautus.
February 23, 2022DrugsFDA
CooperSurgical, Inc recalls PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white ro
Hazard: Non-sterility
February 23, 2022DrugsFDA
Celebrate Today recalls RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Hazard: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
February 23, 2022DrugsFDA
STAQ Pharma, Inc. recalls Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver
Hazard: Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
February 23, 2022DrugsFDA
STAQ Pharma, Inc. recalls HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Den
Hazard: Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
February 23, 2022DrugsFDA
Je Dois Lavoir LLC recalls 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Hazard: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
February 23, 2022DrugsFDA
Your Favorite Shop recalls THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barc
Hazard: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
February 23, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St.
Hazard: Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ANI Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-90
Hazard: cGMP Deviations
February 23, 2022DrugsFDA
ABC Sales 1 Inc recalls MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Hazard: Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
February 23, 2022DrugsFDA
ABC Sales 1 Inc recalls MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Hazard: Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
February 23, 2022DrugsFDA
Aurobindo Pharma USA Inc. recalls Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
Hazard: Failed Impurities/Degradation Specifications
February 23, 2022DrugsFDA
Organics Corporation of America DBA Ambix Laboratories recalls NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for Nature
Hazard: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
February 23, 2022DrugsFDA
Lannett Company, Inc. recalls Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lanne
Hazard: Failed Impurities/Degradation Specifications: Out of specification results for related substances.
February 16, 2022DrugsFDA
Esupplementsales, LLC recalls HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 36492
Hazard: Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
February 16, 2022DrugsFDA
Junp Hydration LLC recalls MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, AS
Hazard: Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
February 16, 2022DrugsFDA
AuroMedics Pharma LLC recalls Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, D
Hazard: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories,
Hazard: CGMP Deviations
February 16, 2022DrugsFDA
ULTRAtab Laboratories, Inc. recalls Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab L
Hazard: CGMP Deviations