Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Aidarex Pharmaceuticals
💊 Drugs Class I - Dangerous
Presence of Foreign Tablets/Capsules
All Recalls
95,075 total recalls in our database
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Milbar Laboratories
💊 Drugs Class I - Dangerous
GMP Deviations
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Sun Pharmaceutical Industries
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-sterile Product
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
💊 Drugs Class I - Dangerous
Defective delivery system
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
💊 Drugs Class I - Dangerous
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
Milbar Laboratories
💊 Drugs Class I - Dangerous
GMP Deviations
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
Sun Pharmaceutical Industries
💊 Drugs Class I - Dangerous
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
🏥 Medical Devices Class I - Dangerous
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
Epic Extremity
🏥 Medical Devices Class I - Dangerous
There is an error in the caddy artwork that misidentifies a specific plate and screw.
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Software anomaly resulting in the loss of patient settings and stored patient data.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Kelyniam Global
🏥 Medical Devices Class I - Dangerous
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.