Home / Recalls / CIPLA / D-0181-2021

D-0181-2021 Class II Terminated

Recalled by CIPLA — Warren, NJ

Recall Details

Product Type
Drugs
Report Date
January 6, 2021
Initiation Date
December 17, 2020
Termination Date
December 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
284,610 packets

Product Description

Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34

Reason for Recall

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: KA00411, KA00412, KA00460, Exp 11/2021

Other recalls by CIPLA

  • D-1550-2022 Class II — Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vi (September 29, 2022)
  • D-1545-2022 Class II — Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 env (September 15, 2022)
  • D-1499-2022 Class II — Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by (August 22, 2022)
  • D-1498-2022 Class II — Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for (August 22, 2022)
  • D-1328-2022 Class II — Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL (August 2, 2022)
  • D-1283-2022 Class II — Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla L (July 14, 2022)
  • D-0660-2021 Class II — Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by (June 10, 2021)
  • D-0182-2021 Class II — Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in uni (December 17, 2020)
  • D-0183-2021 Class II — Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in uni (December 17, 2020)
  • D-0165-2021 Class II — Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only (December 14, 2020)