Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Filters
Showing 6,501–6,520 of 17,964 drug recalls
Drug RecallTerminatedHistorical recordClass II
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
by H J Harkins Company Inc dba Pharma Pac
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
January 6, 2020
Reported by FDA
January 29, 2020
Distribution
Distributed to Physicians in the following states: CA, FL, NC, and SC.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Recall initiated
January 7, 2020
Reported by FDA
January 29, 2020
Distribution
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Recall initiated
January 7, 2020
Reported by FDA
January 29, 2020
Distribution
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
by Hikma Pharmaceuticals USA Inc.
Reason
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
by AuroMedics Pharma LLC
Reason
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India
by Sun Pharmaceutical Industries, Inc.
Reason
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Recall initiated
January 14, 2020
Reported by FDA
January 22, 2020
Distribution
Product was distributed throughout the United States.
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
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.
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