Recall archive
7 recalls · page 1 of 1
Reported Aug 28, 2019
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtech Products, Inc.
Matched: Brand · Product details — CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could…
13 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 20, 2019
Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtech Products, Inc.
Matched: Brand · Product details — Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
FDA (openFDA drug enforcement)
Reported Jun 21, 2017
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bausch & Lomb, Inc.
Matched: Product details — CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
FDA (openFDA drug enforcement)
Reported Jun 10, 2015
SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtech Products, Inc.
Matched: Brand — Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the…
FDA (openFDA drug enforcement)
Reported May 20, 2015
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtech Products, Inc.
Matched: Brand — Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA…
FDA (openFDA drug enforcement)
Reported Jun 4, 2014
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Prestige Brands Holdings
Matched: Product details — Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 12, 2012
Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtech Products, Inc.
Matched: Brand · Product · Product details — Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
FDA (openFDA drug enforcement)
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