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Recall Observatory FDA recall evidence

Drug product

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

D-1416-2015

August 21, 2015

Class III

Product summary

Firm
Silarx Pharmaceutical, Inc.
Event
Event 71952
Status
Terminated
Classification
Class III
Quantity
576 bottles
Official record key
drug-enforcement:D-1416-2015

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

Code information: Lot # 0649A Exp. Date 05/18 (unit carton)

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing