Class I
Terminated
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.
- Company
- Kvk Tech, Inc.
- Recall Initiated
- July 2, 2021
- Posted
- September 1, 2021
- Recall Number
- D-0772-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,692 bottles
- Firm Location
- Newtown, PA, United States
Reason for Recall
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Distribution
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Lot / Code Info
Batch # 16653A, 16654A, Exp 12/2022
More recalls by Kvk Tech, Inc.
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc...
May 28, 2025 · Class II
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940,...
Oct 25, 2023 · Class I
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx...
May 26, 2021 · Class III
Other recent Class I Drug recalls
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025