Why it was recalled
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Product description
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
Lot numbers, UPCs & expiration codes
Lot: RE/030717E, exp 7/2019
Where it was sold
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
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1203-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 23, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 1,869 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hellolife
Original FDA data
Every field from FDA enforcement report D-1203-2018, exactly as published.
Show all FDA fields
- City
- Grand Rapids
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 80893
- Address
- 4460 44th St SE Ste C600
- Code information
- Lot: RE/030717E, exp 7/2019
- Postal code
- 49512-4150
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1203-2018
- Classification
- Class I
- Recalling firm
- Hellolife
- Product quantity
- 1,869 bottles
- Termination date
- Jan 27, 2021
- Reason for recall
- Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
- 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
- Recall initiation date
- Aug 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2018