September 2021 recalls

519 recalls were announced in September 2021.

What the numbers show

Critical: 6
Severe: 98
High: 317
Moderate: 90
Low: 8

Of the 519 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

Which agencies issued them

501–519 of 519

HighFDA (Food)·F-0879-2021·2021-09-01
Hiland Apple Juice Recalled for Elevated Inorganic Arsenic Levels
Hiland Dairy Foods Company LLC is recalling Hiland 100% Pure Apple Juice From Concentrate (4 FL OZ units) due to elevated levels of inorganic arsenic. The recall affects approximately 436,884 units distributed in Arkansas, Missouri, Kansas, Oklahoma, and Texas.
Product
Hiland 100% Pure Apple Juice From Concentrate No Sugar Added Pasteurized 4 FL OZ (118 mL) packaged in paper cartons 75 cartons per case
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-2349-2021·2021-09-01
Vascular Ultrasound Examination Table Recalled for Weld Failure
Oakworks vascular ultrasound examination tables (models USV1 and USV2) are recalled due to potential weld failure in the tilting mechanism bracket. A failed weld could prevent the table from tilting, affecting patient positioning.
Product
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0763-2021·2021-09-01
PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.
Product
PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0758-2021·2021-09-01
PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2339-2021·2021-09-01
OASIS MRI table pads recalled for missing latex allergen labeling
Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.
Product
OASIS MRI System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2336-2021·2021-09-01
KeyPrint Soft Dental Resin Recalled for Incorrect European Labeling
Straumann USA LLC recalled KeyPrint Soft resin bottles (Lot KJ2858) that were distributed with European product labels instead of US-compliant labeling. Dental professionals should verify if they received affected units.
Product
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0760-2021·2021-09-01
PVP Iodine Prep Pads Recalled for Potency Below Specification
Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2333-2021·2021-09-01
BD Mouse IgG2a Antibody Reagent Recalled for Manufacturing Contamination
This antibody reagent was recalled due to manufacturing contamination that may produce false positive staining results in laboratory tests. The affected lot was distributed worldwide.
Product
BD" Mouse IgG2a Isotype Control APC X39 ASR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2334-2021·2021-09-01
FDA Recalls Reprocessed IVUS Catheters Due to Reprocessing Cycle Violation
Northeast Scientific Inc. is recalling 690 reprocessed intravascular ultrasound catheters because they exceed the FDA-approved single reprocessing cycle limit. Devices were distributed nationwide across ten states.
Product
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0757-2021·2021-09-01
Micafungin for Injection recalled for incomplete package insert
Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.
Product
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0756-2021·2021-09-01
Micafungin for Injection Recalled for Incomplete Package Insert
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
Product
Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0764-2021·2021-09-01
PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.
Product
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0762-2021·2021-09-01
PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.
Product
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0761-2021·2021-09-01
PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency
Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
ModerateCPSC·21192·2021-09-01
PetSmart Recalls Top Paw Double Diner Dog Bowls for Laceration Hazard
PetSmart is recalling about 100,300 Top Paw Double Diner Dog Bowls because the gasket on the bottom can come off, leaving a sharp unfinished edge that poses a risk of laceration. Three reports of cuts and scratches have been received.
Product
Top Paw® Double Diner Dog Bowls
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0769-2021·2021-09-01
Erythromycin Topical Solution Recalled for Defective Container Seal
Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.
Product
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0766-2021·2021-09-01
Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.
Product
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0759-2021·2021-09-01
PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient
Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.
Product
PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0771-2021·2021-09-01
Bleomycin for Injection Recalled Due to Mislabeling
Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.
Product
BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
Category
Drug
Distribution
Distributed nationwide

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