February 2021 FDA Recall Fludeoxyglucose F 18 by The General Hospital Corporation
D-0288-2021 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by The General Hospital Corporation on February 17, 2021 for the product Fludeoxyglucose F 18. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed to one direct account. and the recall is currently terminated.
Recall Number: D-0288-2021
Lack of Assurance of Sterility
02-17-2021
03-03-2021
50 mL vial
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
The General Hospital Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to one direct account.
03-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50
Batch or Lot Expiration Information
Lot# P01-021721, exp 02/17/2021
