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Recall Observatory FDA recall evidence

Drug product

Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00

D-0239-2015

September 11, 2013

Class III

Product summary

Firm
Physicians Total Care, Inc.
Event
Event 69595
Status
Terminated
Classification
Class III
Quantity
7,740 pills
Official record key
drug-enforcement:D-0239-2015

Official wording

Reason: Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.

Code information: Lot #: 68GA, 68WE, 6A9W, 6AIT, 6ALI, 6936; Exp. 09/13 Lot #: 6BYA, 6CVI, 6FVX, 6CVH, 6D1W, 6DSH, 6E2V, 6E9W; Exp. 10/13 Lot #: 6HO2, 6I1F; Exp. 11/13 Lot #: 6IG5, 6ILV, 6HCE, 6I7B; Exp. 12/13 Lot #: 6TKA, 6TSZ, 6TUO, 6TXT; Exp. 05/14 Lot #: 6V2S, 6WWJ, 6U9L, 6UQP, 6VJM, 6VSS, 6W3J; Exp. 07/14 Lot #: 6WVP, 6XFX, 6Y99; Exp. 08/14 Lot # :6Y7A; Exp. 10/14

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.