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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87365

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 19, 2021
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Dr. Reddy's Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

D-0291-2021
Recall number
D-0291-2021
Initiated
February 19, 2021
Classification
Class III
Status
Terminated
Quantity
10,440 90-count and 224,710 500-count bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

Code information

a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 T000313 exp 1/2022 T000314 exp 1/2022 T000315 exp 1/2022 T000316 exp 1/2022 T000317 exp 1/2022 T000318 exp 1/2022 T000319 exp 1/2022 T000320 exp 1/2022 T000500 exp 2/2022 T000501 exp 2/2022 T000502 exp 2/2022 T000503 exp 2/2022 T000504 exp 2/2022 T000505 exp 2/2022 T000506 exp 2/2022 T000507 exp 2/2022 T000508 exp 2/2022 T000509 exp 3/2022 T000510 exp 3/2022 T000647 exp 3/2022 T000648 exp 3/2022 T000651exp 3/2022 T000652 exp 3/2022 T000653 exp 3/2022 T000654 exp 3/2022 T000875 exp 4/2022 T000876 exp 4/2022 T000877 exp 4/2022 T000878 exp 4/2022 T000879 exp 4/2022 T000880 exp 4/2022 T000881 exp 4/2022 T000882 exp 4/2022 T000883 exp 4/2022 T000884 exp 4/2022 T001120 exp 5/2022 T001121 exp 5/2022 T001122 exp 5/2022 T001124 exp 5/2022 T001125 exp 5/2022 T001126 exp 5/2022 T001127 exp 5/2022 T001128 exp 5/2022 T001129 exp 5/2022 T001130 exp 5/2022 T001260 exp 5/2022 T001261 exp 5/2022 T900506 exp 4/2021 T900507 exp 4/2021 T900508 exp 4/2021 T900655 exp 5/2021 T900656 exp 5/2021 T900657 exp 5/2021 T900658 exp 5/2021 T900659 exp 5/2021 T900673 exp 5/2021 T900674 exp 5/2021 T901024 exp 7/2021 T901025 exp 7/2021 T901026 exp 7/2021 T901027 exp 7/2021 T901029 exp 7/2021 T901030 exp 7/2021 T901031 exp 7/2021 T901032 exp 7/2021 T901033 exp 7/2021 T901424 exp 10/2021 T901425 exp 10/2021 T901426 exp 10/2021 T901427 exp 10/2021 T901428 exp 10/2021 T901429 exp 10/2021 T901430 exp 10/2021 T901431 exp 10/2021 T901432 exp 10/2021 T901433 exp 10/2021 T901568 exp 10/2021 T901569 exp 10/2021 T901570 exp 11/2021 T901571 exp 11/2021 T901572 exp 11/2021 T901573 exp 11/2021 T901574 exp 11/2021 T901575 exp 11/2021 T901576 exp 11/2021 T901577 exp 11/2021

Distribution pattern

Distributed Nationwide in the USA