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Recall Observatory FDA recall evidence

Drug product

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.

D-1552-2020

July 29, 2020

Class I

Product summary

Firm
SCA Pharmaceuticals
Event
Event 86193
Status
Terminated
Classification
Class I
Quantity
1,527 Containers
Official record key
drug-enforcement:D-1552-2020

Official wording

Reason: 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.

Code information: Lot #: 1220019243, Exp 08/20/2020; 1220019439,1220019279, 1220019392, Exp 08/24/2020; 1220019488, Exp 08/26/2020.

Distribution pattern: Nationwide within the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.