Class I - Dangerous
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I - Dangerous
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Presence of foreign matter
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Subpotent
Class I - Dangerous
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Class I - Dangerous
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I - Dangerous
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class I - Dangerous
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class I - Dangerous
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I - Dangerous
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Class I - Dangerous
Non-Sterility: firm's third party lab confirmed microbial contamination.
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161
Professional Disposables International
Class I - Dangerous
SubPotent: Out of Specification
PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
Professional Disposables International
Class I - Dangerous
SubPotent: Out of Specification