Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0278-2019

D-0278-2019 Class II Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

Recall Details

Product Type
Drugs
Report Date
November 21, 2018
Initiation Date
October 19, 2018
Termination Date
November 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.

Reason for Recall

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 313344, Exp 12/18

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  • D-0375-2022 Class I — Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pha (December 15, 2021)
  • D-0246-2021 Class II — Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceut (January 8, 2021)
  • D-0151-2021 Class II — Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET (November 17, 2020)
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  • D-0156-2021 Class II — RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0. (November 17, 2020)
  • D-0159-2021 Class II — Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (November 17, 2020)