March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b)
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
March 30, 2022DrugsFDA
Blaine Labs Inc recalls REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 2
Hazard: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
March 23, 2022DrugsFDA
Walmart Stores recalls Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Hazard: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of States
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Stat
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
Family Pharmacy of Statesville recalls Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Hazard: Lack of Assurance of Sterility
March 23, 2022DrugsFDA
B. Braun Medical, Inc. recalls 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800
Hazard: Lack of sterility assurance: leaking bags
March 23, 2022DrugsFDA
Golden State Medical Supply Inc. recalls Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GS
Hazard: CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
March 23, 2022DrugsFDA
The Harvard Drug Group recalls hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMA
Hazard: Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
March 16, 2022DrugsFDA
American Health Packaging recalls Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Ins
Hazard: Impurity failure at 0-time of the repackaged lot.
March 16, 2022DrugsFDA
Direct Rx recalls Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Dist
Hazard: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
March 16, 2022DrugsFDA
Direct Rx recalls Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distr
Hazard: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
March 16, 2022DrugsFDA
The Harvard Drug Group recalls PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: S
Hazard: Failed Dissolution Specifications
March 9, 2022DrugsFDA
Morton Grove Pharmaceuticals, Inc. recalls Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceutic
Hazard: Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
March 9, 2022DrugsFDA
Vi-Jon, Inc. recalls HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored clo
Hazard: Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
March 9, 2022DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets pe
Hazard: CGMP deviations
March 9, 2022DrugsFDA
Dollar Tree Distribution, Inc. recalls All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mi
Hazard: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
March 9, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08
Hazard: cGmp Deviations
March 9, 2022DrugsFDA
Direct Rx recalls Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By A
Hazard: Failed impurities/degradation specifications
March 9, 2022DrugsFDA
Tsm Brands LLC recalls Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan,
Hazard: Labeling - product contains undeclared ethyl alcohol
March 9, 2022DrugsFDA
Tsm Brands LLC recalls 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 5
Hazard: Labeling - product contains undeclared ethyl alcohol