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D-1200-2018 Class I Terminated

Recalled by Hellolife — Grand Rapids, MI

FDA drug recall D-1200-2018 was initiated by Hellolife on August 23, 2018 and is designated Class I. Reason for recall: Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia The recall status is terminated (terminated January 27, 2021). Affected quantity: 989 bottles.

Recall Details

Product Type: Drugs
Report Date: September 19, 2018
Initiation Date: August 23, 2018
Termination Date: January 27, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 989 bottles

Product Description

Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02

Reason for Recall

Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia

Distribution Pattern

Nationwide USA, Algeria Australia Belgium Brazil Bulgaria Canada Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Estonia French Polynesia Greece Guadeloupe Guam Hong Kong Hungary India Ireland Israel Italy Latvia Lithuania Martinique Mexico Monaco Netherlands New Zealand Norway Peru Poland Portugal Romania Russia Russian Federation Saudi Arabia Senegal Serbia Slovakia Slovakia (Slovak Republic) Slovenia Swaziland Sweden Switzerland Taiwan Turkey United Kingdom

Code Information

Lot: CO/030717B, exp 7/2019