Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured f...
CGMP Deviations; deficiencies observed during FDA inspection
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
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.
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka...
Failed Impurities/Degradations Specifications
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, R...
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propo...
Microbial Contamination of Non-Sterile Products
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
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, M...
Microbial contamination of 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.
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-d...
Presence of Particulate matter: Particulate matter identified as glass.
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
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable ...
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
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg...
Presence of foreign substance: small metallic particles in chewable tablets.
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, D...
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.
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
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 9...
Presence of foreign substance: small metallic particles in chewable tablets.
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-coun...
Presence of foreign substance: small metallic particles in chewable tablets.
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TA...
Presence of foreign substance: small metallic particles in chewable tablets.
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DI...
Presence of foreign substance: small metallic particles in chewable tablets.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count...
Presence of foreign substance: small metallic particles in chewable tablets.
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distr...
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.