Class I - Dangerous
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
US Pharmaceuticals
Class I - Dangerous
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
Lupin Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
H J Harkins Company Inc
Class I - Dangerous
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
Duren Health Mart Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99
Duren Health Mart Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
Prinston Pharmaceutical
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Sun Pharmaceutical Industries
Class I - Dangerous
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98
Duren Health Mart Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
Duren Health Mart Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
Duren Health Mart Pharmacy
Class I - Dangerous
Lack of Processing Controls.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01
Duren Health Mart Pharmacy
Class I - Dangerous
Lack of Processing Controls.