Home / Recalls / KVK-Tech, Inc. / D-1371-2015

D-1371-2015 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
September 2, 2015
Initiation Date
July 14, 2015
Termination Date
January 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,696 bottles (100-count), 972 bottles (1000-count)

Product Description

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA

Reason for Recall

Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Distribution Pattern

Nationwide

Code Information

Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017

Other recalls by KVK-Tech, Inc.

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  • D-0772-2021 Class I — Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: K (July 2, 2021)
  • 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-1032-2014 Class II — HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mf (December 11, 2013)