D-0299-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- September 27, 2019
- Termination Date
- August 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 639,325 bottles
Product Description
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9
Reason for Recall
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: J78402968, J784129698, Exp 9/19; K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, Exp 10/19; A887230568, A887330568, A887430568, Exp 12/19; B865430568, B865530568, B865630568, B869530568, B869630568, Exp 1/20; D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, Exp 3/20; E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, Exp 4/20; F865131834, Exp 5/20; G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, Exp 6/20; H865232436, H865332436, H870832436, Exp 7/20; I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, Exp 8/20; J868533164, J868633164, J868733164, J868833164, J868933164 and J869033164, Exp 9/20; L866434042, L866534043, L866634044, L866734045, L866834046, L866934422, Exp 11/20; A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, Exp 12/20; B974034749, B974134750, B974234751, B974334752, B974434753, Exp 1/21