Waco, TX, United States
Allergan Sales, LLC recalls
2 recalls recorded since 2018, most recently on 14 March 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 March 2024
- Reason
- Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1694-2024
- Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Terminated Class II Drugs
- Recall started
- 19 March 2019
- Terminated
- 29 April 2020
- Reason
- cGMP Deviations
- Distribution
- TN only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1056-2019
- Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.