Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Showing 11,341–11,360 of 17,974 drug recalls
Drug RecallTerminatedHistorical recordClass II
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
by Amgen, Inc.
Reason
Lack of Assurance of Sterility: Potential cracks in glass vials
Recall initiated
December 15, 2016
Reported by FDA
December 28, 2016
Distribution
United States and Puerto Rico No foreign distribution.
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
by Les Emballages Knowlton Inc.
Reason
Labeling: Label Mix Up- Incorrect back label applied to the product.
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.
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
by Love My Tru Body
Reason
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
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
by Sperian Eye & Face Protection, Inc
Reason
Non Sterility; contaminated with Klebsiella pneumoniae
Recall initiated
August 16, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
by Ultimate Body Tox
Reason
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.
Recall initiated
November 13, 2016
Reported by FDA
December 28, 2016
Distribution
Product distributed in NC and nationwide through the internet.
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12
by Cantrell Drug Company
Reason
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75
by Cantrell Drug Company
Reason
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15
by Cantrell Drug Company
Reason
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30
by Cantrell Drug Company
Reason
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
by Cantrell Drug Company
Reason
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75
by Cantrell Drug Company
Reason
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
