Class I - Dangerous
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total 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
Class I - Dangerous
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class I - Dangerous
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
West-Ward Pharmaceutical
Class I - Dangerous
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Class I - Dangerous
Presence of Particulate Matter; particulate found in retain samples
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
Class I - Dangerous
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Class I - Dangerous
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
Bayer HealthCare Pharmaceuticals
Class I - Dangerous
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Class I - Dangerous
Subpotent Drug; 15-month stability test station
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class I - Dangerous
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
American Health Packaging
Class I - Dangerous
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
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.
Class I - Dangerous
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Class I - Dangerous
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes