D-0224-2016 Class II Terminated
FDA drug recall D-0224-2016 was initiated by The Compounder on Mar 10, 2015 and is designated Class II. Reason for recall: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. The recall status is terminated (terminated May 19, 2016). Affected quantity: 10 (3mL) syringes, 20 (1mL) syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 18, 2015
- Initiation Date
- Mar 10, 2015
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 (3mL) syringes, 20 (1mL) syringes
Product Description
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.
Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Distribution Pattern
Nationwide
Code Information
a) Lot # 12292014:32@20, Exp 6/27/2015; b) Lot # 01082015:73@21, Exp 7/7/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0224-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026