Recalls / Class II
Class IIF-0266-2017
Product
Poly-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
- Type
- Food
- Affected lot / code info
- NDC No. 0904-5099-50; Lot No. 20701509 & 20701511, Exp. Date 09/2017; Lot No. 20701513, Exp. Date 12/2017; Lot No. 20701601, Exp. Date 02/2018; Lot No. 20701602 & 20701603, Exp. Date 04/2018; Lot No. 20701606, Exp. Date 06/2016.
- Quantity
- 42,984 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-0266-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings.