March 15, 2017
More than 4020 cartons of DUOPA (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg/mL, were recalled in Tennessee and Illinois.
The US Food and Drug Administration (FDA) classified the recall as Class II on February 27, 2017, as the product may cause a temporary health problem or pose “only a slight threat of a serious nature.”
DUOPA is used in individuals with advanced Parkinson’s disease for the treatment of motor fluctuations.
The Class II recall was prompted due to failed stability specifications. More specifically, the latest FDA Enforcement Report states that confirmed out of specification results were obtained “during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life.”
The recall was voluntarily initiated by AbbVie Inc on January 13, 2017. According to the FDA report, the recall is completed, meaning that AbbVie Inc has retrieved and impounded all outstanding products that “could reasonably be expected to be recovered, or has completed all product corrections.”
The recalled prescription product is packaged in 100-mL single-use cassettes, with each carton containing 7 cassettes, and has the following code information:
- Lot number 1055692, expiration date (Frozen) 06/01/2018
- Lot number 1057881, expiration date (Frozen) 06/02/2018
- Lot number 1060138, expiration date (Frozen) 06/13/2018
- Lot number 1060140, expiration date (Frozen) 06/15/2018
- Lot number 1061258, expiration date (Frozen) 06/17/2018
- Lot number 1061262, expiration date (Frozen) 06/30/2018
- Lot number 1063033, expiration date (Frozen) 07/14/2018
-Meredith Edwards White