Class III · Low risk Terminated
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC…
Reason LABELING: LABEL MIX-UP.
Is Apple recalled?
13 FDA recalls mention Apple. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Apple.
Class II · Moderate risk Terminated
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains…
Reason Discoloration
Class II · Moderate risk Ongoing
SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a)…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class I · High risk Terminated
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Reason Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Class III · Low risk Terminated
Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA…
Reason Labeling mix-up - Indications on product label are incorrect.
Class II · Moderate risk Terminated
CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL)…
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class III · Low risk Terminated
CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class II · Moderate risk Terminated
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
Reason Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Class II · Moderate risk Terminated
REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc…
Reason Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea.
Class III · Low risk Terminated
Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH…
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class II · Moderate risk Terminated
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets…
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL)…
Reason Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
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