Home / Recalls / Dr. Reddy's Laboratories, Inc. / D-0878-2018

D-0878-2018 Class II Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
June 27, 2018
Initiation Date
May 30, 2018
Termination Date
December 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,397 bottles

Product Description

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

Reason for Recall

Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: T800064, Exp 12/2019

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  • D-0525-2025 Class II — Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manu (June 30, 2025)
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  • D-0117-2025 Class III — Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, (November 22, 2024)
  • D-0047-2025 Class III — IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Red (October 29, 2024)
  • D-0036-2025 Class II — Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, (October 22, 2024)
  • D-0037-2025 Class II — Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Ma (October 22, 2024)
  • D-0027-2025 Class II — Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories I (October 9, 2024)
  • D-0028-2025 Class II — Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories In (October 9, 2024)