Recalls / Class II
Class IIF-3530-2017
Product
Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)
- Type
- Food
- Affected lot / code info
- Leader Liquid Multivitamin Supplement for Infants and Toddlers 1 2/3 oz (50 mL), UPC Number: 096295128611, All Unexpired Lots
- Quantity
- 3,840 units
Why it was recalled
The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, N/A, Livonia, Michigan 48152-3951
Distribution
- Distribution pattern
- Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
Timeline
- Recall initiated
- 2017-08-02
- FDA classified
- 2017-09-12
- Posted by FDA
- 2017-09-20
- Terminated
- 2020-04-28
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-3530-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.