Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class I - Dangerous
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class I - Dangerous
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
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.
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.