Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
Morton Grove Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
Grupo Asimex de Mexico SA de CV
Class I - Dangerous
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I - Dangerous
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Class I - Dangerous
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class I - Dangerous
Lack of processing controls
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Meitheal Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Ebay Seller - John Nguyen
Class I - Dangerous
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Prescription Labs Inc
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Superpotent Drug
Class I - Dangerous
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01
Rhodes Pharmaceuticals, L.P.
Class I - Dangerous
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
Grupo Asimex de Mexico SA de CV
Class I - Dangerous
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I - Dangerous
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
Class I - Dangerous
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
Class I - Dangerous
Subpotent
Class I - Dangerous
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.