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RETACRIT™ (epoetin alfa-epbx) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

RETACRIT (epoetin alfa-epbx) injection is a sterile, clear, and colorless solution in single-dose and multiple-dose vials available as:

Unit of SaleStrengthEach Single Unit of Use
NDC 0069-1305-10
Carton containing 10 vials
2,000 Units/mLNDC 0069-1305-01
1 mL Single-dose vial
NDC 0069-1306-10
Carton containing 10 vials
3,000 Units/mLNDC 0069-1306-01
1 mL Single-dose vial
NDC 0069-1307-10
Carton containing 10 vials
4,000 Units/mLNDC 0069-1307-01
1 mL Single-dose vial
NDC 0069-1308-10
Carton containing 10 vials
10,000 Units/mLNDC 0069-1308-01
1 mL Single-dose vial
NDC 0069-1309-10
Carton containing 10 vials
40,000 Units/mLNDC 0069-1309-01
1 mL Single-dose vial
NDC 0069-1309-04
Carton containing 4 vials
40,000 Units/mLNDC 0069-1309-01
1 mL Single-dose vial
NDC 0069-1318-10
Carton containing 10 vials with a freeze strip indicator
20,000 Units/2 mL
(10,000 Units/mL)
NDC 0069-1318-01
2 mL Multiple-dose vial
NDC 0069-1318-04
Carton containing 4 vials with a freeze strip indicator
20,000 Units/2 mL
(10,000 Units/mL)
NDC 0069-1318-01
2 mL Multiple-dose vial
NDC 0069-1311-10
Carton containing 10 vials with a freeze strip indicator
20,000 Units/mLNDC 0069-1311-01
1 mL Multiple-dose vial
NDC 0069-1311-04
Carton containing 4 vials with a freeze strip indicator
20,000 Units/mLNDC 0069-1311-01
1 mL Multiple-dose vial

Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. When exposed to freezing temperatures, the green area of the freeze strip indicator in the carton of the multiple-dose vials will show signs of cloudy or white discoloration.

Do not shake. Do not use RETACRIT that has been shaken or frozen or if the green area of the freeze strip indicator is cloudy or white.

Store RETACRIT vials in the original carton until use to protect from light.

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