Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules...
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, M...
Microbial contamination of sterile products
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC ...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propo...
Microbial Contamination of Non-Sterile Products
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (U...
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, M...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by:...
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle...
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-d...
Presence of Particulate matter: Particulate matter identified as glass.
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewabl...
Presence of foreign substance: small metallic particles in chewable tablets.
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Dis...
Presence of foreign substance: small metallic particles in chewable tablets.
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable t...
Presence of foreign substance: small metallic particles in chewable tablets.
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed ...
Lack of Assurance of Sterility
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable ...
Presence of foreign substance: small metallic particles in chewable tablets.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-coun...
Presence of foreign substance: small metallic particles in chewable tablets.
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle,...
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharm...
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHE...
Presence of foreign substance: small metallic particles in chewable tablets.
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharm...
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-coun...
Presence of foreign substance: small metallic particles in chewable tablets.
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 9...
Presence of foreign substance: small metallic particles in chewable tablets.
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable ...
Presence of foreign substance: small metallic particles in chewable tablets.
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 che...
Presence of foreign substance: small metallic particles in chewable tablets.
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg...
Presence of foreign substance: small metallic particles in chewable tablets.