Skip to content
Recall Observatory FDA recall evidence

Drug product

CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

D-0384-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
284,232 units
Official record key
drug-enforcement:D-0384-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: RJK 10/19 SBJ 2/20 SFG 6/20 SHI 8/20 SLB 12/20 TCM 03/21 TDC 4/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility