Drug recall D-0772-2021

Class I Terminated reported Sep 1, 2021

Product

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

Reason for recall

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

Lots and codes

Batch # 16653A, 16654A, Exp 12/2022

Recall details

Recalling firm
KVK-Tech, Inc., Newtown, PA
Quantity
1,692 bottles
Distribution
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
July 2, 2021
Terminated
May 23, 2022

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