Food, drugs, devices › Paddock Laboratories, LLC.
Drug recall: Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for
FDA enforcement event 79334 is a drug recall by Paddock Laboratories, LLC. of New Hope, MN, initiated 26 Feb 2018 and classified Class II, with 1 product record.
FDA defines Class II as 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 16 Jul 2020. Initiation: voluntary: firm initiated. Paddock Laboratories, LLC. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Paddock Laboratories, LLC., New Hope, MN.
Reason for recall
"Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product."
Distribution
"Nationwide within the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0608-2018 | Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27 | 52,596 bottles | Class II | Terminated | 4 Apr 2018 |
Context
Other enforcement events for Paddock Laboratories, LLC.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Mar 2014 | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01 | Drug | Class II | 1 |
| 3 Oct 2012 | Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 , | Drug | Class II | 1 |
All 3 events for Paddock Laboratories, LLC.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.