Traceback investigation into an outbreak of Salmonella Newport illnesses found red onions to be a suspect vehicle for the outbreak. After notification from FDA, firm initiated a recall.
All Recalls
95,025 total recalls in our database
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Par Pharmaceutical
💊 Drugs Class I - Dangerous
Failed Impurity /Degradation Specifications
HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013
RESOURCE RECOVERY & TRADING
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
💊 Drugs Class I - Dangerous
Cross Contamination with other products: trace amounts of lidocaine
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01
BAYSHORE PHARMACEUTICALS
💊 Drugs Class I - Dangerous
CGMP Deviations
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
RESOURCE RECOVERY & TRADING
💊 Drugs Class I - Dangerous
cGMP deviations
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
Yusef Manufacturing Laboratories
💊 Drugs Class I - Dangerous
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
💊 Drugs Class I - Dangerous
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
💊 Drugs Class I - Dangerous
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
💊 Drugs Class I - Dangerous
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
💊 Drugs Class I - Dangerous
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
💊 Drugs Class I - Dangerous
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
💊 Drugs Class I - Dangerous
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
💊 Drugs Class I - Dangerous
Discoloration and Presence of Foreign Substance
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
Hetero Labs Limited (Unit V)
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specification; complaint of bulging tablet
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
BAYSHORE PHARMACEUTICALS
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
🏥 Medical Devices Class I - Dangerous
Potential Endotoxin Contamination
🏥 Medical Devices Class I - Dangerous
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.