Recalls / Class II
Class IIF-0259-2017
Product
Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
- Type
- Food
- Affected lot / code info
- UPC No. 005360650858; Lot No. 22461511 & 22461512, Exp. Date 10/2017; Lot No. 22461513 & 22461514, Exp. Date 11/2017; Lot No. 22461515 & 22461516, Exp. Date 12/2017; Lot No. 22461601 & 22461602, Exp. Date 02/2018; Lot No. 22461603 & 22461604, Exp. Date 04/2018; Lot No. 22461605 & 22461606, Exp. Date 05/2018.
- Quantity
- 75,972 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-0259-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.