Fjk726.pdf

Tetracycline Hydrochloride Capsules Finished Product
Material Safety Data Sheet
SECTION 1 - IDENTIFICATION
PRODUCT NAME
SYNONYMS
CHEMICAL FAMILY
THERAPEUTIC
CATEGORY
SECTION 2 – HEALTH HAZARD INFORMATION
EMERGENCY
WARNING – The information in this MSDS is based on the hazards of the OVERVIEW
active ingredient. While diluted, this material may present the following hazards – POTENTIAL SENSITIZER AND REPRODUCTIVE HAZARD.
EYE
SKIN
INGESTION
INHALATION
Inhalation may cause irritation of the respiratory tract. ADVERSE SYSTEMIC
Photosensitivity (excessive sunburn reaction). Benign intracranial EFFECTS
hypertension with headache and blurred vision. Nausea, vomiting, diarrhea, genital area yeast infection, hypersensitivity skin reactions, reduced blood cell counts, elevated liver enzymes, jaundice.
CHRONIC (CANCER)
INFORMATION
REPRODUCTION INFO Tooth discoloration and retarded bone development has been found after
exposure in the last half of pregnancy.
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Tetracycline Hydrochloride Capsules Finished Product
Material Safety Data Sheet
MEDICAL
Hypersensitivity to material, impaired kidney or liver function, and CONDITIONS/MEDS
AGGRAVATED BY
EXPOSURE
TARGET ORGANS
APPEARANCE
ODOR
SECTION 3 – INGREDIENT INFORMATION
COMPONENT
CAS NUMBER
% BY WEIGHT
SECTION 4 – FIRST AID MEASURES
EYES
Flush with large quantities of water for 15 minutes. SKIN
Brush off material; remove contaminated clothing, flush with large quantities of water for 15 minutes. INGESTION
Flush mouth with water – obtain medical attention. INHALATION
NOTE TO PHYSICIANS
SECTION 5 – FIRE FIGHTING MEASURES
FLAMMABLE
PROPERTIES
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Tetracycline Hydrochloride Capsules Finished Product
Material Safety Data Sheet
HAZARDOUS
Emits toxic fumes under fire conditions. COMBUSTION
PRODUCTS
EXTINGUISHING
Water spray, dry chemical, carbon dioxide or foam as appropriate for MEDIA
FIRE FIGHTING
As with all fires, evacuate personnel to a safe area. Firefighters should use INSTRUCTION
self-contained breathing equipment and protective clothing. SECTION 6 – ACCIDENTAL RELEASE MEASURES
SPILL
Wear appropriate PPE. Scoop up slowly without breaking capsules and generating dust. (NO DRY SWEEPING). Wet wipe surfaces. SECTION 7 – HANDLING AND STORAGE
HANDLING
Keep container closed, minimize dust generation during transfer. STORAGE
SECTION 8 – EXPOSURE CONTROL AND PPE
ENGINEERING
Operations involving handling/transferring of dry power should be CONTROLS
performed using containment measures (i.e. enclosures, etc.) and local exhaust ventilation. RESPIRATORY
Wear appropriate PPE according to dust level. PROTECTION
SKIN PROTECTION
Wear appropriate PPE according to dust level. EYE PROTECTION
Wear appropriate PPE according to dust level. COMPONENT
EXPOSURE LIMIT
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Tetracycline Hydrochloride Capsules Finished Product
Material Safety Data Sheet
SECTION 9 – PHYSICAL AND CHEMICAL PROPERTIES
BOILING POINT
MELTING
pH
POINT
VAPOR PRESSURE
VAPOR
DENSITY
SOLUBILITY IN
ODOR
WATER
APPEARANCE
SPECIFIC
GRAVITY
AUTOIGNITION
FLAMMABLE
TEMPERATURE
LIMITS
MOLECULAR WEIGHT
FLASHPOINT
OCTANOL/WATER
EVAPORATION No information found.
COEFFICIENT
RATE
SECTION 10 – STABILITY AND REACTIVITY
CHEMICAL STABILITY This material is considered stable from a safety point of view.
(CONDITIONS TO
AVOID)
INCOMPATIBILITY
HAZARDOUS
When heated to decomposition, material emits toxic fumes.
DECOMPOSITION
PRODUCTS
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Tetracycline Hydrochloride Capsules Finished Product
Material Safety Data Sheet
HAZARDOUS
POLYMERIZATION
SECTION 11 – TOXICOLOGICAL INFORMATION
EYE
SKIN
INGESTION
INHALATION
ACUTE/SUBCHRONIC
MUTAGENICITY/
Animal studies have not shown evidence of mutagenicity or CARCINOGENICITY
REPRODUCTION
Animal studies have shown evidence of teratogenicity and no evidence of impaired fertility.
SECTION 12 – ECOLOGICAL INFORMATION
ECOTOXICOLOGICAL
INFORMATION
CHEMICAL FATE
INFORMATION
SECTION 13 – DISPOSAL CONSIDERATIONS
Dispose of in accordance with all applicable federal, state, and local regulations. SECTION 14 – TRANSPORTATION INFORMATION
Finished products in final packaging ready for consumer use are NOT regulated by DOT. Page 5 of 6
Tetracycline Hydrochloride Capsules Finished Product
Material Safety Data Sheet
SECTION 15 – REGULATORY INFORMATION
OSHA
CERCLA
SECTION 313 (SARA
TITLE III)
OTHER REGULATIONS API is subject to California Proposition 65 (known to the state as a
reproductivetoxicant) warning and release requirements April 1, 1990 and the California Safe Drinking Water and Toxic Enforcement Act of 1986 to keep out of water supplies and sewers.
SECTION 16 – OTHER INFORMATION
PREPARED BY
REVISIONS
DISCLAIMER:
Teva Pharmaceuticals USA, Inc. provides the information contained in this MSDS sheet in good faith but makes no claim as to its accuracy or Comprehensiveness. This MSDS sheet is intended as a guide for a properly trained person to utilize appropriate precautionary methods while handling this product. Individuals must exercise their own judgment in determining the appropriateness of this information for a particular purpose. All MSDS sheets are subject to revision from time-to-time as new information becomes available. Anyone proposing to rely on information regarding the substance that is the subject of this MSDS sheet is responsible for ensuring that he or she has obtained and reviewed the most recent version of the sheet available at the time. Teva Pharmaceuticals USA, Inc. will not be responsible for damages resulting from the use or misuse of the information contained in this MSDS sheet. Page 6 of 6

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