Recalls / Class II
Class IIF-0269-2017
Product
Ferrous Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Type
- Food
- Affected lot / code info
- NDC No. 0904-6060-50; Lot No. 20901509 & 20901510, Exp. Date 11/2017; Lot No. 20901601, Exp. Date 02/2018; Lot No. 20901602, Exp. Date 03/2018; Lot No. 20901603, Exp. Date 05/2018.
- Quantity
- 31,224 bottles
Why it was recalled
Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.
Recalling firm
- Firm
- Pharmatech LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4131 SW 47th Ave Ste 1403, Davie, Florida 33314-4036
Distribution
- Distribution pattern
- FL, MI, MS, and OH.
Timeline
- Recall initiated
- 2016-08-08
- FDA classified
- 2016-10-25
- Posted by FDA
- 2016-11-02
- Terminated
- 2024-09-23
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0269-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.