Drug product
ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
D-0224-2016
Product summary
- Firm
- the Compounder
- Event
- Event 71535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 (3mL) syringes, 20 (1mL) syringes
- Official record key
drug-enforcement:D-0224-2016
Official wording
Reason: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Code information: a) Lot # 12292014:32@20, Exp 6/27/2015; b) Lot # 01082015:73@21, Exp 7/7/2015
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.