Recalls / Class II
Class IID-1781-2019
Product
Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 1748 MG / 250 ML NS IVPB; Gemcitabine 890 MG /250 ML NS IVPB Gemcitabine 2000 MG /250 ML 0.9% NACL IVPB; Gemcitabine 660 MG / 250 ML NS IVPB; Gemcitabine 1880 MG /250 ML NS IVPB; Gemcitabine 1180 MG / 250 ML NS IVPB; Gemcitabine 1400 MG / 250 ML NS IVPB Gemcitabine 1300 MG / 250 ML NS IVPB; Gemcitabine 1406 MG /250 ML NS IVPB; Gemcitabine 1672 MG / 250 ML NS IVPB; Gemcitabine 2050 MG / 250 ML NS IVPB; Gemcitabine 1260 MG / 250 ML NS IVPB; Gemcitabine 1710 MG / 250 ML NS IVPB; Gemcitabine 1320 MG / 250 ML NS IVPB; Gemcitabine 1200 MG /250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Affected lot / code info
- All lots within expiry
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Infusion Options, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5924 13th Ave, N/A, Brooklyn, New York 11219-4934
Distribution
- Quantity
- N/A
- Distribution pattern
- NY only
Timeline
- Recall initiated
- 2019-06-12
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1781-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.