App Pharmaceuticals Llc: CGMP Deviations: Incomplete documentation associated with test results.

Agency Publication Date: June 19, 2012

Affected Products

Product: HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

Lot 406952 (Expiration Date 02/11)

Lot Numbers:

406952

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 57878

Status: Resolved

Manufacturer: App Pharmaceuticals Llc

Manufactured In: United States

Units Affected: 133,150 vials

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Sources: FDA iRES · Raw API Response

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Medium RiskFDA Device