Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
All Recalls
95,018 total recalls in our database
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Amerisource Health Services
Subpotent Drug
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
Aire-Master of America
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Aire-Master of America
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
KY JELLY LUBRICANT 2 FL OZ, SKU 901443
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
FIRST RESPONSE 2 CT, SKU 902343
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Micro Therapeutics
Outer carton packaging of microcatheters were exposed to wet substance during transport.
CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box
DENTEMP ONE STEP .077OZ, SKU 902139
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Stradis Medical, LLC
The sterile barrier may be compromised.
GS SALINE SOLUTION 12FL OZ, SKU 902274
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
Family Dollar Stores
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.