Home / Recalls / KVK-Tech, Inc. / D-0772-2021

D-0772-2021 Class I Terminated

Recalled by KVK-Tech, Inc. — Newtown, PA

Recall Details

Product Type
Drugs
Report Date
September 1, 2021
Initiation Date
July 2, 2021
Termination Date
May 23, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,692 bottles

Product Description

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.

Distribution Pattern

Product was distributed to one distributor who may have further distributed Nationwide in the USA.

Code Information

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

Other recalls by KVK-Tech, Inc.

  • D-0049-2024 Class I — Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., (September 20, 2023)
  • D-0386-2021 Class III — Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, (April 27, 2021)
  • D-0224-2021 Class III — Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx O (December 18, 2020)
  • D-0532-2020 Class II — Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg p (November 1, 2019)
  • D-0142-2020 Class III — Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Fr (October 4, 2019)
  • D-0340-2019 Class II — Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK- (December 11, 2018)
  • D-1083-2017 Class III — Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702 (August 3, 2017)
  • D-1057-2016 Class III — Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KV (May 5, 2016)
  • D-1371-2015 Class III — Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (July 14, 2015)
  • D-1032-2014 Class II — HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mf (December 11, 2013)