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Recall Observatory FDA recall evidence

Food product

Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701

F-0817-2017

July 28, 2014

Class III

Product summary

Firm
Hi-Tech Pharmacal Co., Inc.
Event
Event 68873
Status
Terminated
Classification
Class III
Quantity
22,872 bottles
Official record key
food-enforcement:F-0817-2017

Official wording

Reason: Out-of-specification results for pH.

Code information: Lot 618283 (Exp. 01/2015), Lot 620151 (Exp. 03/2015), Lot 623407 (Exp. 09/2015) --- EXTENSION: Lots 620915 (Expiry 04/2015), 622298 (Exp. 07/2015), 624881 (Exp. 12/2015), 625981 (Exp. 02/2016), 626967 (Exp. 04/2016), 627676 (Exp. 05/2016).

Distribution pattern: CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, VT and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification