Class I - Dangerous
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
💊
Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Ultimate Body Tox
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Colonia Care Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Sperian Eye & Face Protection
Class I - Dangerous
Non Sterility; contaminated with Klebsiella pneumoniae
Class I - Dangerous
Failed Dissolution Specifications; 6 month time point
Class I - Dangerous
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
Meta Pharmacy Services
Class I - Dangerous
Lack of Sterility Assurance
Class I - Dangerous
Defective delivery system: detached needles on the syringe in the kit.
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
Les Emballages Knowlton
Class I - Dangerous
Labeling: Label Mix Up- Incorrect back label applied to the product.
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
VIRTUS PHARMACEUTICALS OPCO II L
Class I - Dangerous
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Inventia Healthcare Private Limited
Class I - Dangerous
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Hospira Inc., A Pfizer Company
Class I - Dangerous
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Colonia Care Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
VIRTUS PHARMACEUTICALS OPCO II L
Class I - Dangerous
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I - Dangerous
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.