Taro Pharmaceuticals U.S.A., Inc.: 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 b

Is my product affected?

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

• Brand IBUPROFEN

Check against the official notice below — it lists the full affected range.

What happened

Taro Pharmaceuticals U.S.A., Inc. is recalling Ibuprofen Oral Suspension USP 100 mg/5 mL (one pint/473 mL bottles) distributed nationwide because the product may contain small particles of inert plastic material that were introduced during manufacturing. The recall affects 639,325 bottles across multiple lots with expiration dates ranging from September 2019 through January 2021.

The source document does not specify what consumers should do if they have affected product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Details from the source

Reason for recall: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. Distribution: U.S.A. Nationwide Quantity: 639,325 bottles Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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