Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Other Drugs
💊 Drugs • 3,200 recalls
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Max Huber Research Labs
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Max Huber Research Labs
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.
Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
Mission Pharmacal
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Failed Stability Specifications: Unable to meet shelf life expiry.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box, Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438. (Club Pack), NDC 0067-6295-43
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.